Name: Equipment Validation Training Course (ONLINE) – For Starter Validation, CQV and C&Q Roles
Price: 2399 GBP
Availability: InStock

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					<div><p>The Essentials of European Medical Device Regulations course provides a comprehensive overview of the EU MDR, covering everything from classification and reporting to quality systems. You'll learn from experienced professionals and gain the knowledge and skills to successfully ensure your devices comply with the latest regulations and bring them to market.</p><p>In the first section, you will explore the European Medical Device Regulations (EU MDR). Picture yourself gaining a bird's-eye view of the regulatory framework governing European medical devices. As you delve into the essential components of EU MDR in Section 02, envision yourself gaining a profound understanding of device classification, conformity assessment procedures, and the intricacies of clinical evaluations. It's a voyage of discovery that lays the foundation for your expertise.</p><p>Now, picture yourself in Section 03, where you dive into the depths of reporting requirements and identification. You'll acquire the knowledge and confidence to navigate adverse event reporting and product seamlessly recalls. Finally, in Section 04, envision yourself immersed in the world of quality systems within medical device regulation. Gain the skills to ensure product safety and efficacy while adhering to the highest industry standards.</p><p>By completing this course, you'll emerge as a knowledgeable and adept professional ready to conquer the challenges of European Medical Device Regulations. Whether you're a seasoned industry expert seeking to sharpen your skills or a newcomer eager to embark on a rewarding healthcare career, this course is your gateway to success. Join us on this captivating journey and become a master of European medical device compliance.</p><p>Are you ready to embark on a transformative journey through the intricacies of European Medical Device Regulations? Enroll today and unlock the secrets to compliance, quality, and success in the healthcare industry.</p></div>
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			<h2><b> Learning outcome</b></h2>		</div>
				</div>
				<div>
				<div>
					<ul>
							<li>
											<span>
													</span>
										<span>Master the fundamentals of European Medical Device Regulations.</span>
									</li>
								<li>
											<span>
													</span>
										<span>Understand the key components of EU MDR, including classification and conformity assessment.</span>
									</li>
								<li>
											<span>
													</span>
										<span>Learn how to navigate reporting requirements and handle identification in compliance with regulations.</span>
									</li>
								<li>
											<span>
													</span>
										<span>Gain proficiency in quality systems integral to medical device regulation.</span>
									</li>
								<li>
											<span>
													</span>
										<span>Acquire the skills needed to ensure product safety and efficacy.</span>
									</li>
						</ul>
				</div>
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			<h2> <b>Why should I take this course?</b></h2>		</div>
				</div>
				<div>
				<div>
					<ul>
							<li>
											<span>
													</span>
										<span>Gain a comprehensive understanding of the EU MDR and its requirements</span>
									</li>
								<li>
											<span>
													</span>
										<span>Learn from experienced professionals who have helped companies comply with the EU MDR</span>
									</li>
								<li>
											<span>
													</span>
										<span>Get the knowledge and skills you need to ensure your devices comply with the latest regulations and bring them to market successfully</span>
									</li>
								<li>
											<span>
													</span>
										<span>Stay ahead of the curve and avoid costly mistakes</span>
									</li>
								<li>
											<span>
													</span>
										<span>Protect the safety and well-being of your patients</span>
									</li>
						</ul>
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			<h2> <b>Career Path</b></h2>		</div>
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					<ul>
							<li>
											<span>
													</span>
										<span>Regulatory Affairs Specialist</span>
									</li>
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													</span>
										<span>Quality Assurance Manager</span>
									</li>
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													</span>
										<span>Medical Device Consultant</span>
									</li>
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													</span>
										<span>Clinical Research Associate</span>
									</li>
								<li>
											<span>
													</span>
										<span>Compliance Analyst</span>
									</li>
						</ul>
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			<h2> <b>Requirements</b></h2>		</div>
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					<ul>
							<li>
											<span>
													</span>
										<span>Basic knowledge of medical devices and healthcare regulations.</span>
									</li>
								<li>
											<span>
													</span>
										<span>Access to a computer with internet connectivity.</span>
									</li>
								<li>
											<span>
													</span>
										<span>A desire to excel in the field of medical device regulation.</span>
									</li>
						</ul>
				</div>
				</div>
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		</section><div>
                            <div>
                                <h2>Course Curriculum</h2>
                            </div>
                            			<div>
				

<div>
<table width="100%">				<tbody><tr>
					<td colspan="4"><strong>Section 01: Overview to European Regulations on Medical Devices</strong></td>
				</tr>
								<tr>
					<td>▶</td>
					<td>Overview to European Regulations on Medical Devices</td><td><span>🕐 00:33:00</span></td>
				</tr>
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					<td colspan="4"><strong>Section 02: Essential Components of EU MDR</strong></td>
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					<td>▶</td>
					<td>Essential Components of EU MDR</td><td><span>🕐 00:29:00</span></td>
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					<td colspan="4"><strong>Section 03: Reporting Requirements and Identification</strong></td>
				</tr>
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					<td>▶</td>
					<td>Reporting Requirements and Identification</td><td><span>🕐 00:16:00</span></td>
				</tr>
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					<td colspan="4"><strong>Section 04: Quality System in Medical Device Regulation</strong></td>
				</tr>
								<tr>
					<td>▶</td>
					<td>Quality System in Medical Device Regulation</td><td><span>🕐 00:25:00</span></td>
				</tr>
				</tbody></table></div>

			</div>
		                        </div>

The Essentials of European Medical Device Regulations course provides a comprehensive overview of the EU MDR, covering everything from classification and reporting to quality systems. You'll learn from experienced professionals and gain the knowledge and skills to successfully ensure your devices comply with the latest regulations and bring them to market.
In the first section, you will explore the European Medical Device Regulations (EU MDR). Picture yourself gaining a bird's-eye view of the regulatory framework governing European medical devices. As you delve into the essential components of EU MDR in Section 02, envision yourself gaining a profound understanding of device classification, conformity assessment procedures, and the intricacies of clinical evaluations. It's a voyage of discovery that lays the foundation for your expertise.
Now, picture yourself in Section 03, where you dive into the depths of reporting requirements and identification. You'll acquire the knowledge and confidence to navigate adverse event reporting and product seamlessly recalls. Finally, in Section 04, envision yourself immersed in the world of quality systems within medical device regulation. Gain the skills to ensure product safety and efficacy while adhering to the highest industry standards.
By completing this course, you'll emerge as a knowledgeable and adept professional ready to conquer the challenges of European Medical Device Regulations. Whether you're a seasoned industry expert seeking to sharpen your skills or a newcomer eager to embark on a rewarding healthcare career, this course is your gateway to success. Join us on this captivating journey and become a master of European medical device compliance.
Are you ready to embark on a transformative journey through the intricacies of European Medical Device Regulations? Enroll today and unlock the secrets to compliance, quality, and success in the healthcare industry.
 Learning outcome
Master the fundamentals of European Medical Device Regulations.
Understand the key components of EU MDR, including classification and conformity assessment.
Learn how to navigate reporting requirements and handle identification in compliance with regulations.
Gain proficiency in quality systems integral to medical device regulation.
Acquire the skills needed to ensure product safety and efficacy.
 Why should I take this course?
Gain a comprehensive understanding of the EU MDR and its requirements
Learn from experienced professionals who have helped companies comply with the EU MDR
Get the knowledge and skills you need to ensure your devices comply with the latest regulations and bring them to market successfully
Stay ahead of the curve and avoid costly mistakes
Protect the safety and well-being of your patients
 Career Path
Regulatory Affairs Specialist
Quality Assurance Manager
Medical Device Consultant
Clinical Research Associate
Compliance Analyst
 Requirements
Basic knowledge of medical devices and healthcare regulations.
Access to a computer with internet connectivity.
A desire to excel in the field of medical device regulation.
Course Curriculum
Section 01: Overview to European Regulations on Medical Devices			
▶	Overview to European Regulations on Medical Devices	🕐 00:33:00
Section 02: Essential Components of EU MDR			
▶	Essential Components of EU MDR	🕐 00:29:00
Section 03: Reporting Requirements and Identification			
▶	Reporting Requirements and Identification	🕐 00:16:00
Section 04: Quality System in Medical Device Regulation			
▶	Quality System in Medical Device Regulation	🕐 00:25:00

Skill Up

Medical Device Development

Medical Education

Master the European Medical Device Regulations (EU MDR) with this comprehensive course. Gain the knowledge and skills you need to comply with the EU MDR and successfully bring your medical devices to market.

Essentials of European Medical Device Regulations

General Admission

<p>Delve into the intricacies of European medical device regulatory frameworks with our comprehensive course, '<strong>Essentials of European Medical Device Regulations</strong>.' This meticulously structured program provides an in-depth exploration of the critical components and legislative requirements necessary for navigating the complex landscape of medical device regulations in Europe. The first module introduces the foundational aspects of the European regulations, setting the stage for a deeper understanding of the legal and procedural elements that govern this sector. As the course progresses, participants will gain a thorough grasp of the Essential Components of EU MDR (Module 2), the pivotal aspects of Reporting Requirements and Identification (Module 3), and the integral role of Quality Systems in medical device regulation (Module 4). This course is meticulously designed to cater to the needs of professionals seeking a robust understanding of the regulatory environment, ensuring they are well-equipped to adhere to and implement these critical regulations.</p>
<p><strong>Learning Outcomes</strong></p>
<ul>
<li>Acquire a solid foundation in the basic principles and framework of European regulations on medical devices.</li>
<li>Understand the key elements of the EU Medical Device Regulation (MDR) and their application in the industry.</li>
<li>Gain insights into the specific requirements for reporting and identification within the European regulatory context.</li>
<li>Learn about the implementation and management of quality systems in compliance with medical device regulations.</li>
<li>Develop the ability to interpret and apply regulatory guidelines in professional settings, enhancing compliance and operational efficiency.</li>
</ul>
<h3><b>Why choose this Essentials of European Medical Device Regulations<span> course</span>?</b></h3>
<ol>
<li>Unlimited access to the course for a lifetime.</li>
<li>Opportunity to earn a certificate accredited by the <b>CPD Quality Standards</b> and <b>CIQ </b>after completing this course.</li>
<li>Structured lesson planning in line with industry standards.</li>
<li>Immerse yourself in innovative and captivating course materials and activities.</li>
<li>Assessments designed to evaluate advanced cognitive abilities and skill proficiency.</li>
<li>Flexibility to complete the Course at your own pace, on your own schedule.</li>
<li>Receive full tutor support throughout the week, from Monday to Friday, to enhance your learning experience.</li>
<li>Unlock career resources for CV improvement, interview readiness, and job success.</li>
</ol>
<h3><b>Who is this Essentials of European Medical Device Regulations<span> </span></b><b><span>course </span></b><b>for?</b></h3>
<ul>
<li>Professionals in the medical device industry seeking to deepen their understanding of EU regulations.</li>
<li>Regulatory affairs specialists aiming to stay updated with the latest European legislative changes.</li>
<li>Quality assurance personnel in the healthcare sector requiring knowledge of regulatory compliance.</li>
<li>Medical device manufacturers and distributors needing to align their products with EU standards.</li>
<li>Healthcare consultants and advisors focusing on European medical device regulatory frameworks.</li>
</ul>
<h3><b>Career path</b></h3>
<ul>
<li><strong>Regulatory Affairs Manager</strong>: £40,000 - £60,000</li>
<li><strong>Quality Assurance Specialist</strong>: £35,000 - £50,000</li>
<li><strong>Compliance Officer</strong>: £30,000 - £45,000</li>
<li><strong>Product Development Engineer</strong>: £33,000 - £55,000</li>
<li><strong>Healthcare Consultant</strong>: £45,000 - £70,000</li>
<li><strong>Medical Device Auditor</strong>: £37,000 - £53,000</li>
</ul>
<h3><b>Prerequisites</b></h3>
<p><span>This </span><b>Essentials of European Medical Device Regulations</b><span> does not require you to have any prior qualifications or experience. You can just enrol and start learning. This </span><span>course</span><span> was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection.</span></p>
<h3><b>Certification</b></h3>
<p><span>After studying the course materials, there will be a written assignment test which you can take at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £4.99 Original Hard Copy certificates need to be ordered at an additional cost of £8.</span></p><div>
				<h3>
	<span>Course Curriculum</span>
</h3>

<div>
<table width="100%">				<tbody><tr>
					<td colspan="4">Module 1: Overview to European Regulations on Medical Devices</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Overview to European Regulations on Medical Devices</td>
					<td> </td>
					<td><span><i></i> 00:43:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 2: Essential Components of EU MDR</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Essential Components of EU MDR</td>
					<td> </td>
					<td><span><i></i> 00:40:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 3: Reporting Requirements and Identification</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Reporting Requirements and Identification</td>
					<td> </td>
					<td><span><i></i> 00:27:00</span></td>
				</tr>
								<tr>
					<td colspan="4">Module 4: Quality System in Medical Device Regulation</td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Quality System in Medical Device Regulation</td>
					<td> </td>
					<td><span><i></i> 00:36:00</span></td>
				</tr>
				</tbody></table></div>

			</div>

Delve into the intricacies of European medical device regulatory frameworks with our comprehensive course, 'Essentials of European Medical Device Regulations.' This meticulously structured program provides an in-depth exploration of the critical components and legislative requirements necessary for navigating the complex landscape of medical device regulations in Europe. The first module introduces the foundational aspects of the European regulations, setting the stage for a deeper understanding of the legal and procedural elements that govern this sector. As the course progresses, participants will gain a thorough grasp of the Essential Components of EU MDR (Module 2), the pivotal aspects of Reporting Requirements and Identification (Module 3), and the integral role of Quality Systems in medical device regulation (Module 4). This course is meticulously designed to cater to the needs of professionals seeking a robust understanding of the regulatory environment, ensuring they are well-equipped to adhere to and implement these critical regulations.
Learning Outcomes
Acquire a solid foundation in the basic principles and framework of European regulations on medical devices.
Understand the key elements of the EU Medical Device Regulation (MDR) and their application in the industry.
Gain insights into the specific requirements for reporting and identification within the European regulatory context.
Learn about the implementation and management of quality systems in compliance with medical device regulations.
Develop the ability to interpret and apply regulatory guidelines in professional settings, enhancing compliance and operational efficiency.
Why choose this Essentials of European Medical Device Regulations course?
Unlimited access to the course for a lifetime.
Opportunity to earn a certificate accredited by the CPD Quality Standards and CIQ after completing this course.
Structured lesson planning in line with industry standards.
Immerse yourself in innovative and captivating course materials and activities.
Assessments designed to evaluate advanced cognitive abilities and skill proficiency.
Flexibility to complete the Course at your own pace, on your own schedule.
Receive full tutor support throughout the week, from Monday to Friday, to enhance your learning experience.
Unlock career resources for CV improvement, interview readiness, and job success.
Who is this Essentials of European Medical Device Regulations course for?
Professionals in the medical device industry seeking to deepen their understanding of EU regulations.
Regulatory affairs specialists aiming to stay updated with the latest European legislative changes.
Quality assurance personnel in the healthcare sector requiring knowledge of regulatory compliance.
Medical device manufacturers and distributors needing to align their products with EU standards.
Healthcare consultants and advisors focusing on European medical device regulatory frameworks.
Career path
Regulatory Affairs Manager: £40,000 - £60,000
Quality Assurance Specialist: £35,000 - £50,000
Compliance Officer: £30,000 - £45,000
Product Development Engineer: £33,000 - £55,000
Healthcare Consultant: £45,000 - £70,000
Medical Device Auditor: £37,000 - £53,000
Prerequisites
This Essentials of European Medical Device Regulations does not require you to have any prior qualifications or experience. You can just enrol and start learning. This course was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection.
Certification
After studying the course materials, there will be a written assignment test which you can take at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £4.99 Original Hard Copy certificates need to be ordered at an additional cost of £8.
 Course Curriculum

Module 1: Overview to European Regulations on Medical Devices			
	Overview to European Regulations on Medical Devices		00:43:00
Module 2: Essential Components of EU MDR			
	Essential Components of EU MDR		00:40:00
Module 3: Reporting Requirements and Identification			
	Reporting Requirements and Identification		00:27:00
Module 4: Quality System in Medical Device Regulation			
	Quality System in Medical Device Regulation		00:36:00

Studyhub UK

MRCS

European Computer Driving Licence (ECDL)

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					<div><p>Gain the skills and credentials to kickstart a successful career and learn from the experts with this step-by-step training course. This European Medical Device Regulations  has been specially designed to help learners gain a good command of European Medical Device Regulations , providing them with a solid foundation of knowledge to become a qualified professional.</p><p>Through this European Medical Device Regulations , you will gain both practical and theoretical understanding of European Medical Device Regulations  that will increase your employability in this field, help you stand out from the competition and boost your earning potential in no time.</p><p>Not only that, but this training includes up-to-date knowledge and techniques that will ensure you have the most in-demand skills to rise to the top of the industry. This qualification is fully accredited, broken down into several manageable modules, ideal for aspiring professionals.</p></div>
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			<h2><b> Learning outcome</b></h2>		</div>
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					<ul>
							<li>
											<span>
													</span>
										<span>Familiar yourself with the recent development and updates of the relevant industry</span>
									</li>
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										<span>Know how to use your theoretical knowledge to adapt in any working environment</span>
									</li>
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											<span>
													</span>
										<span>Get help from our expert tutors anytime you need</span>
									</li>
								<li>
											<span>
													</span>
										<span>Access to course contents that are designed and prepared by industry professionals</span>
									</li>
								<li>
											<span>
													</span>
										<span>Study at your convenient time and from wherever you want</span>
									</li>
						</ul>
				</div>
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			<h2> <b>Why should I take this course?</b></h2>		</div>
				</div>
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					<ul>
							<li>
											<span>
													</span>
										<span>Affordable premium-quality E-learning content, you can learn at your own pace.</span>
									</li>
								<li>
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													</span>
										<span>You will receive a completion certificate upon completing the course.</span>
									</li>
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										<span>Internationally recognized Accredited Qualification will boost up your resume.</span>
									</li>
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											<span>
													</span>
										<span>You will learn the researched and proven approach adopted by successful people to transform their careers.</span>
									</li>
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											<span>
													</span>
										<span>You will be able to incorporate various techniques successfully and understand your customers better.</span>
									</li>
						</ul>
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			<h2> <b>Requirements</b></h2>		</div>
				</div>
				<div>
				<div>
					<ul>
							<li>
											<span>
													</span>
										<span>No formal qualifications required, anyone from any academic background can take this course.</span>
									</li>
								<li>
											<span>
													</span>
										<span>Access to a computer or digital device with internet connectivity.</span>
									</li>
						</ul>
				</div>
				</div>
						</div>
			</div>
		</div>
						</div>
			</div>
		</section><div>
                            <div>
                                <h2>Course Curriculum</h2>
                            </div>
                            			<div>
				

<div>
<table width="100%">				<tbody><tr>
					<td colspan="4"><strong>Module 1: Overview to European Regulations on Medical Devices</strong></td>
				</tr>
								<tr>
					<td>▶</td>
					<td>Overview to European Regulations on Medical Devices</td><td><span>🕐 00:45:00</span></td>
				</tr>
								<tr>
					<td colspan="4"><strong>Module 2: Essential Components of EU MDR</strong></td>
				</tr>
								<tr>
					<td>▶</td>
					<td>Essential Components of EU MDR</td><td><span>🕐 00:42:00</span></td>
				</tr>
								<tr>
					<td colspan="4"><strong>Module 3: Reporting Requirements and Identification</strong></td>
				</tr>
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					<td>▶</td>
					<td>Reporting Requirements and Identification</td><td><span>🕐 00:29:00</span></td>
				</tr>
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					<td colspan="4"><strong>Module 4: Quality System in Medical Device Regulation</strong></td>
				</tr>
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					<td>▶</td>
					<td>Quality System in Medical Device Regulation</td><td><span>🕐 00:38:00</span></td>
				</tr>
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					<td colspan="4"><strong>Mock Exam</strong></td>
				</tr>
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					<td><i></i></td>
					<td>Mock Exam - European Medical Device Regulations</td><td><span>🕐 00:20:00</span></td>
				</tr>
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					<td colspan="4"><strong>Final Exam</strong></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Final Exam - European Medical Device Regulations</td><td><span>🕐 00:20:00</span></td>
				</tr>
								<tr>
					<td colspan="4"><strong>Order Your Certificate</strong></td>
				</tr>
								<tr>
					<td><i></i></td>
					<td>Order Your Certificate</td><td><span>🕐 00:00:00</span></td>
				</tr>
				</tbody></table></div>

			</div>
		                        </div>

Gain the skills and credentials to kickstart a successful career and learn from the experts with this step-by-step training course. This European Medical Device Regulations has been specially designed to help learners gain a good command of European Medical Device Regulations , providing them with a solid foundation of knowledge to become a qualified professional.
Through this European Medical Device Regulations , you will gain both practical and theoretical understanding of European Medical Device Regulations that will increase your employability in this field, help you stand out from the competition and boost your earning potential in no time.
Not only that, but this training includes up-to-date knowledge and techniques that will ensure you have the most in-demand skills to rise to the top of the industry. This qualification is fully accredited, broken down into several manageable modules, ideal for aspiring professionals.
 Learning outcome
Familiar yourself with the recent development and updates of the relevant industry
Know how to use your theoretical knowledge to adapt in any working environment
Get help from our expert tutors anytime you need
Access to course contents that are designed and prepared by industry professionals
Study at your convenient time and from wherever you want
 Why should I take this course?
Affordable premium-quality E-learning content, you can learn at your own pace.
You will receive a completion certificate upon completing the course.
Internationally recognized Accredited Qualification will boost up your resume.
You will learn the researched and proven approach adopted by successful people to transform their careers.
You will be able to incorporate various techniques successfully and understand your customers better.
 Requirements
No formal qualifications required, anyone from any academic background can take this course.
Access to a computer or digital device with internet connectivity.
Course Curriculum
Module 1: Overview to European Regulations on Medical Devices			
▶	Overview to European Regulations on Medical Devices	🕐 00:45:00
Module 2: Essential Components of EU MDR			
▶	Essential Components of EU MDR	🕐 00:42:00
Module 3: Reporting Requirements and Identification			
▶	Reporting Requirements and Identification	🕐 00:29:00
Module 4: Quality System in Medical Device Regulation			
▶	Quality System in Medical Device Regulation	🕐 00:38:00
Mock Exam			
	Mock Exam - European Medical Device Regulations	🕐 00:20:00
Final Exam			
	Final Exam - European Medical Device Regulations	🕐 00:20:00
Order Your Certificate			
	Order Your Certificate	🕐 00:00:00

Certificate in Further Education & Training (Cert Ed)

Medical Training

Certificate in Education & Training (CET)

Trainers Course

Gain the skills and credentials to kickstart a successful career and learn from the experts with this step-by-step

European Medical Device Regulations

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			<h2>Overview
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					<p><span>This comprehensive course on </span><b><span>European Medical Device Regulations</span></b> will deepen your understanding on this topic.</p><p><span><span>After successful completion of this course you can acquire the required skills in this sector. This </span><b>European Medical Device Regulations</b> comes with accredited certification, which will enhance your CV and make you worthy in the job market.</span></p><p><span><span>So enrol in this course today to fast track your career ladder.</span></span></p>					</div>
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			<h2>How will I get my certificate?</h2>		</div>
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					<p>You may have to take a quiz or a written test online during or after the course. After successfully completing the course, you will be eligible for the certificate.</p>					</div>
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			<h2>Who is This course for?</h2>		</div>
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					<p><span>There is no experience or previous qualifications required for enrolment on this </span><b><span>European Medical Device Regulations</span></b>. It is available to all students, of all academic backgrounds.</p>					</div>
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			<h2>Requirements</h2>		</div>
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					<p><span>Our </span><b><span>European Medical Device Regulations</span></b> is fully compatible with PC's, Mac's, Laptop, Tablet and Smartphone devices. This course has been designed to be fully compatible with tablets and smartphones so you can access your course on Wi-Fi, 3G or 4G.</p><p><span><span>There is no time limit for completing this course, it can be studied in your own time at your own pace.</span></span></p>					</div>
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			<h2>Career Path</h2>		</div>
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					<p><span>Having these various qualifications will increase the value in your CV and open you up to multiple sectors such as Business &amp; Management, Admin, Accountancy &amp; Finance, Secretarial &amp; PA, Teaching &amp; Mentoring etc.</span></p>					</div>
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		</section>
						</div>
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					</div> <h3>Course Curriculum</h3><div><p>1 sections • 4 lectures • 02:26:00 total length</p></div><div><div><div><div><div><div><div><p>•Module 1: Overview to European Regulations on Medical Devices: 00:43:00</p></div><div><div><p>•Module 2: Essential Components of EU MDR: 00:40:00</p></div><div><div><p>•Module 3: Reporting Requirements and Identification: 00:27:00</p></div><div><div><p>•Module 4: Quality System in Medical Device Regulation: 00:36:00</p></div></div></div></div></div></div></div></div></div></div>

Overview

This comprehensive course on European Medical Device Regulations will deepen your understanding on this topic.
After successful completion of this course you can acquire the required skills in this sector. This European Medical Device Regulations comes with accredited certification, which will enhance your CV and make you worthy in the job market.
So enrol in this course today to fast track your career ladder.
How will I get my certificate?
You may have to take a quiz or a written test online during or after the course. After successfully completing the course, you will be eligible for the certificate.
Who is This course for?
There is no experience or previous qualifications required for enrolment on this European Medical Device Regulations. It is available to all students, of all academic backgrounds.
Requirements
Our European Medical Device Regulations is fully compatible with PC's, Mac's, Laptop, Tablet and Smartphone devices. This course has been designed to be fully compatible with tablets and smartphones so you can access your course on Wi-Fi, 3G or 4G.
There is no time limit for completing this course, it can be studied in your own time at your own pace.
Career Path
Having these various qualifications will increase the value in your CV and open you up to multiple sectors such as Business & Management, Admin, Accountancy & Finance, Secretarial & PA, Teaching & Mentoring etc.
Course Curriculum
1 sections • 4 lectures • 02:26:00 total length
•Module 1: Overview to European Regulations on Medical Devices: 00:43:00
•Module 2: Essential Components of EU MDR: 00:40:00
•Module 3: Reporting Requirements and Identification: 00:27:00
•Module 4: Quality System in Medical Device Regulation: 00:36:00

Apex Learning

Certificate in Emergency Response Ambulance Driving (CERAD)

<p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;"><b data-stringify-type="bold" fr-original-style=" color: rgb(209, 210, 211);" style="color: rgb(209, 210, 211); box-sizing: border-box;" id="isPasted"><span fr-original-style="color: rgb(0, 0, 0);" style="color: rgb(0, 0, 0); box-sizing: border-box;">Welcome to Medical Gas Safety 101: Minimizing Risks in Healthcare Settings. In this course, you&#39;ll learn:</span></b></p><ol style="color: rgb(209, 213, 219); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(209, 213, 219);"><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);"><p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;"><strong style="color: var(--tw-prose-bold); font-weight: 700; box-sizing: border-box;" fr-original-style=" color: var(--tw-prose-bold);">Introduction to Medical Gases:</strong></p><ul style="color: initial; box-sizing: border-box;" fr-original-style="color: initial;"><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Gain a foundational understanding of the various medical gases used in healthcare.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Explore the properties, classifications, and applications of medical gases.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Understand the regulatory framework and standards governing the use of medical gases.</li></ul></li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);"><p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;"><strong style="color: var(--tw-prose-bold); font-weight: 700; box-sizing: border-box;" fr-original-style=" color: var(--tw-prose-bold);">Safety and Handling Guidelines:</strong></p><ul style="color: initial; box-sizing: border-box;" fr-original-style="color: initial;"><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Learn essential safety protocols and guidelines for the handling of medical gases.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Explore risk assessment and mitigation strategies to enhance workplace safety.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Understand the importance of proper labeling, signage, and communication in preventing accidents.</li></ul></li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);"><p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;"><strong style="color: var(--tw-prose-bold); font-weight: 700; box-sizing: border-box;" fr-original-style=" color: var(--tw-prose-bold);">Common Medical Gases:</strong></p><ul style="color: initial; box-sizing: border-box;" fr-original-style="color: initial;"><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Delve into the specific properties and applications of commonly used medical gases.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Discuss the therapeutic uses of oxygen, nitrous oxide, carbon dioxide, and other gases.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Explore the potential hazards associated with each gas and effective preventive measures.</li></ul></li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);"><p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;"><strong style="color: var(--tw-prose-bold); font-weight: 700; box-sizing: border-box;" fr-original-style=" color: var(--tw-prose-bold);">Storage, Transportation, and Documentation:</strong></p><ul style="color: initial; box-sizing: border-box;" fr-original-style="color: initial;"><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Learn best practices for the safe storage and transportation of medical gases.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Understand the regulatory requirements for documentation and record-keeping.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Explore strategies for inventory management to ensure a consistent and reliable supply.</li></ul></li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);"><p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;"><strong style="color: var(--tw-prose-bold); font-weight: 700; box-sizing: border-box;" fr-original-style=" color: var(--tw-prose-bold);">Administration Techniques and Monitoring:</strong></p><ul style="color: initial; box-sizing: border-box;" fr-original-style="color: initial;"><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Gain insights into the various methods of administering medical gases.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Explore the principles of dosage calculation and administration techniques.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Understand the importance of continuous monitoring and assessment during gas administration.</li></ul></li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);"><p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;"><strong style="color: var(--tw-prose-bold); font-weight: 700; box-sizing: border-box;" fr-original-style=" color: var(--tw-prose-bold);">Practical Skills and Simulation:</strong></p><ul style="color: initial; box-sizing: border-box;" fr-original-style="color: initial;"><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Apply theoretical knowledge through hands-on practical exercises.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Engage in realistic simulations to develop critical decision-making skills.</li><li style="color: rgb(0, 0, 0); box-sizing: border-box;" fr-original-style="color: rgb(0, 0, 0);">Enhance proficiency in handling emergencies related to medical gas administration.</li></ul></li></ol>

Welcome to Medical Gas Safety 101: Minimizing Risks in Healthcare Settings. In this course, you'll learn:
Introduction to Medical Gases:Gain a foundational understanding of the various medical gases used in healthcare.Explore the properties, classifications, and applications of medical gases.Understand the regulatory framework and standards governing the use of medical gases.
Safety and Handling Guidelines:Learn essential safety protocols and guidelines for the handling of medical gases.Explore risk assessment and mitigation strategies to enhance workplace safety.Understand the importance of proper labeling, signage, and communication in preventing accidents.
Common Medical Gases:Delve into the specific properties and applications of commonly used medical gases.Discuss the therapeutic uses of oxygen, nitrous oxide, carbon dioxide, and other gases.Explore the potential hazards associated with each gas and effective preventive measures.
Storage, Transportation, and Documentation:Learn best practices for the safe storage and transportation of medical gases.Understand the regulatory requirements for documentation and record-keeping.Explore strategies for inventory management to ensure a consistent and reliable supply.
Administration Techniques and Monitoring:Gain insights into the various methods of administering medical gases.Explore the principles of dosage calculation and administration techniques.Understand the importance of continuous monitoring and assessment during gas administration.
Practical Skills and Simulation:Apply theoretical knowledge through hands-on practical exercises.Engage in realistic simulations to develop critical decision-making skills.Enhance proficiency in handling emergencies related to medical gas administration.

John Academy

Explore the intricacies of medical gas safety with our comprehensive course, 'Medical Gas Safety 101.' Master safety protocols, handling guidelines, and administration techniques to minimize risks in healthcare settings. Enhance your skills through hands-on simulations and gain the expertise needed to ensure patient safety and regulatory compliance. Join us for a transformative learning experience in the dynamic field of medical gas management

Medical Gas Safety 101: Minimizing Risks in Healthcare Settings


<p>Unlock the secrets to navigating the intricate landscape of European medical device regulations with our comprehensive course. Designed for those who seek mastery in understanding and applying the latest EU standards, this course is your gateway to compliance excellence. Dive deep into the regulatory environment, where you'll explore the essential components that govern the medical device industry in Europe. Learn how to seamlessly integrate these regulations into your practice, ensuring your products meet the highest standards of safety and efficacy.</p><p><strong>Key Features:</strong></p><ul><li>CPD Certified </li><li>Free Certificate from Reed</li><li>CIQ Approved</li><li>Developed by Specialist</li><li>Lifetime Access </li></ul><p>Discover the nuances of reporting requirements and identification processes, critical for maintaining transparency and accountability. Our expertly curated content guides you through establishing a robust quality system, pivotal for regulatory success. Equip yourself with the knowledge to confidently manage regulatory submissions and navigate quality audits with ease. Join a community of like-minded professionals and elevate your regulatory expertise, ensuring your organisation stays ahead in the competitive medical device market. Enrol now to transform your approach to European medical device regulations and lead with confidence in a compliant and efficient manner.</p><p><strong>Course Curriculum</strong></p><ul><li>Module 01: Overview to European Regulations on Medical Devices</li><li>Module 02: Essential Components of EU MDR</li><li>Module 03: Reporting Requirements and Identification</li><li>Module 04: Quality System in Medical Device Regulation</li></ul><p><strong>Learning Outcomes:</strong></p><ul><li>Understand the core elements of European medical device regulations.</li><li>Identify key components of EU Medical Device Regulation (MDR).</li><li>Master reporting requirements and device identification processes.</li><li>Implement quality systems in medical device regulation.</li><li>Analyse essential EU MDR regulatory requirements.</li><li>Navigate the complexities of EU medical device compliance.</li></ul><h2>
        
        <div>CPD</div>
    </h2>

                        <div id="cpd">
                            <div>
                                <div>
                                    <div>
                                        10 CPD hours / points
                                    </div>
                                        <div>
                                            Accredited by CPD Quality Standards
                                        </div>
                                </div>
                            </div>
                        </div><li>
                                        <h3>
                                            
                                                Essential Components of European Medical Device Regulations <span>1:45:07</span>
                                                <span></span>
                                            
                                        </h3>
                                        <ul id="section1">
                                                <li>
                                                    <span>1: Module 01: Overview to European Regulations on Medical Devices		</span>

                                                    <span>33:17</span>

                                                        
                                                                                                                                                                                                            </li>
                                                <li>
                                                    <span>2: Module 02: Essential Components of EU MDR		</span>

                                                    <span>29:12</span>

                                                        
                                                                                                                                                                                                            </li>
                                                <li>
                                                    <span>3: Module 03: Reporting Requirements and Identification		</span>

                                                    <span>16:21</span>

                                                        
                                                                                                                                                                                                            </li>
                                                <li>
                                                    <span>4: Module 04: Quality System in Medical Device Regulation</span>

                                                    <span>25:17</span>

                                                        
                                                                                                                                                                                                            </li>
                                                <li>
                                                    <span>5: CPD Certificate - Free</span>

                                                    <span>01:00</span>

                                                                                                                                                                
                                                                                                    </li>
                                        </ul>
                                    </li><h2>
        
        <div>Who is this course for?</div>
    </h2>

                        <div id="who_is_this_course_for">
                            <ul><li>Regulatory affairs specialists in the medical device industry.</li><li>Quality assurance professionals in healthcare.</li><li>Compliance officers in medical device companies.</li><li>Medical device product managers.</li><li>Legal advisors in healthcare regulation.</li></ul>
                        </div><h2>
        
        <div>Career path</div>
    </h2>

                        <div id="career_path">
                            <ul><li>Regulatory Affairs Specialist</li><li>Quality Assurance Manager</li><li>Compliance Officer</li><li>Medical Device Consultant</li><li>Product Manager</li><li>Regulatory Affairs Associate</li></ul>
                        </div><h2>
        
        <div>Certificates</div>
    </h2>

                        <div id="optional_extras">
                                    <h4>Digital certificate</h4>
        <p>
            Digital certificate -
            Included
        </p>
        <h4>Reed Courses Certificate of Completion</h4>
        <p>
            Digital certificate -
            Included
        </p>
            <div><p>Will be downloadable when all lectures have been completed.</p></div>

                        </div>

Unlock the secrets to navigating the intricate landscape of European medical device regulations with our comprehensive course. Designed for those who seek mastery in understanding and applying the latest EU standards, this course is your gateway to compliance excellence. Dive deep into the regulatory environment, where you'll explore the essential components that govern the medical device industry in Europe. Learn how to seamlessly integrate these regulations into your practice, ensuring your products meet the highest standards of safety and efficacy.
Key Features:
CPD Certified
Free Certificate from Reed
CIQ Approved
Developed by Specialist
Lifetime Access
Discover the nuances of reporting requirements and identification processes, critical for maintaining transparency and accountability. Our expertly curated content guides you through establishing a robust quality system, pivotal for regulatory success. Equip yourself with the knowledge to confidently manage regulatory submissions and navigate quality audits with ease. Join a community of like-minded professionals and elevate your regulatory expertise, ensuring your organisation stays ahead in the competitive medical device market. Enrol now to transform your approach to European medical device regulations and lead with confidence in a compliant and efficient manner.
Course Curriculum
Module 01: Overview to European Regulations on Medical Devices
Module 02: Essential Components of EU MDR
Module 03: Reporting Requirements and Identification
Module 04: Quality System in Medical Device Regulation
Learning Outcomes:
Understand the core elements of European medical device regulations.
Identify key components of EU Medical Device Regulation (MDR).
Master reporting requirements and device identification processes.
Implement quality systems in medical device regulation.
Analyse essential EU MDR regulatory requirements.
Navigate the complexities of EU medical device compliance.
 CPD 
10 CPD hours / points  Accredited by CPD Quality Standards
Essential Components of European Medical Device Regulations 1:45:07   1: Module 01: Overview to European Regulations on Medical Devices 33:17  2: Module 02: Essential Components of EU MDR 29:12  3: Module 03: Reporting Requirements and Identification 16:21  4: Module 04: Quality System in Medical Device Regulation 25:17  5: CPD Certificate - Free 01:00
 Who is this course for? 
Regulatory affairs specialists in the medical device industry.
Quality assurance professionals in healthcare.
Compliance officers in medical device companies.
Medical device product managers.
Legal advisors in healthcare regulation.
 Career path 
Regulatory Affairs Specialist
Quality Assurance Manager
Compliance Officer
Medical Device Consultant
Product Manager
Regulatory Affairs Associate
 Certificates 
Digital certificate
 Digital certificate - Included 
Reed Courses Certificate of Completion
 Digital certificate - Included 
Will be downloadable when all lectures have been completed.

Online Training Academy

Certified Manager of Quality

Continuous Professional Development (CPD)

Essential Components of European Medical Device Regulations

Getreskilled (UK)

Pharmaceutical

Biomedical Engineering

Engineering

Has the Computer System Validation Engineer left and you’ve been handed their responsibilities? Do the thoughts of your next audit fill you with dread? CSV can be frustrating but this program will show you how to manage electronic data in a regulated manufacturing/laboratory/clinical environment using the GAMP framework and ensure compliance with FDA’s 21 CFR Part 11, EU Annex 11 or other regulatory guidelines.

Computer System Validation Training Course (ONLINE). Extend Your Role to CSV Projects. Get Certified and Become a CSV Professional

Full Price

1/3 Monthly Instalments

Enrol a Team of 5 People

Want a more senior validation engineer, CQV or C&Q job with a higher salary? Take our level 7 University Certificate in Validation Training Course. Develop process validation protocols, Plan a validation strategy. Develop a validation master plan for the entire lifecycle of a product. Give yourself a competitive edge in the marketplace. Developed in consultation with the pharma industry including Pfizer and MSD. University Accredited by TU Dublin Ireland.
Turn your validation work experience into a university accredited certificate
Get a more interesting job with a higher salary. Charge higher hourly rates.
Estimated salaries €45,000 – €100,000 plus overtime, bonuses and allowances. (Based on Irish job data)
NFQ: Level 7
Application Deadline: Wednesday 19th July
Study Online part-time 14 hrs/week
3 Modules over 30 Weeks
Dedicated course leader who’ll check your progress at the end of every week and follow up with you to help you finish the course
Join 1330 Learners

UNIVERSITY ACCREDITEDApply NOW & retrain more senior validation, CQV or C&Q roles
University Accredited by TU Dublin Ireland
This Certificate is Accredited by a World Top 4% University

Technological University Dublin (TUD) is one of the largest universities in Ireland
Named Best Institute of Technology by the Sunday Times in 2010
Ranked in the top 100 by the Times Higher Education for universities under 50 in 2014 and 2015
28,500 registered students
Over 2,000 members of staff
See Course Price
Our learners work for the world’s biggest pharma and medical device companies












This course is right for you if:
You want to turn your validation work experience into a University Certification and charge higher hourly rates.
You want more Senior Validation Engineer, Technician, CQV or C&Q roles and higher pay.
Your work in Quality Assurance/Quality Control but have to sign off on validation documents you don’t fully understand!
You don’t want to waste your time or money on hotel or travel junkets.
Delivered part-time online so you can learn from home (or anywhere). Study after the kids have gone to bed.
Develop Process Validation Protocols
For a validated process to meet the requirements of a regulatory audit.
Plan a Validation Strategy
From the development of a validation master plan for the entire lifecycle of a product.
Develop an Industry Portfolio
Give yourself a competitive edge when applying for jobs.
Join a Validation Team
You’ll have working knowledge of the everyday activities of a Validation Team.
Minimum Entry Requirements:
You must be able to answer “YES” to ALL of the following 4 questions for this “Certificate in Validation”
Do you have a sound understanding of GMP rules, regulations and guidelines?
Can you read engineering documentation such as P&IDs and piping isometrics?
Do you understand IQ, OQ and PQ?
Can you populate an IQ OQ PQ Equipment Qualification protocol used in the BioPharma/Medtech Industry?
NOTE:
If you answer “NO” to any of the 4 questions above, you will first need to take our Equipment Validation Training Course (ONLINE) – For Starter Validation Roles and learn commissioning & qualification of equipment and systems and how to populate an IQ OQ PQ Equipment Qualification Protocol. This program covers all the entry requirements above.
See Course Price
What you’ll learn – There are three 10-week modules in this 30-week program
Module 1 – Pharmaceutical Facility Design (Weeks 1-10)
In this module, you will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpins an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.
Module 2 – Planning a Validation Strategy (Weeks 11-20)
In this module, you will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpins an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.
Module 3 – From URS to PQ – a Validation Project (Weeks 21-30)
This is a workshop driven module where you will develop a P&ID and then back-engineer it into a URS (User Requirement Specification) which will be used to identify the key process measurements that will form the basis of the Performance Qualification (PQ) test script
View Full 30 Week Syllabus
What Kind of Roles Would I be Suitable For?
The more validation work experience you have, the better positioned you’ll be to successfully apply for more senior roles upon completion of the program. Here are some of the most common job titles we see advertised and the expected salaries.
Validation Technician
Works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result.
Some companies might call this role:
CQV Specialist
C&Q Specialist
Associate QA Validation Specialist
C&Q Junior Project Manager
Equipment & Process Validation Specialist
QA Validation Associate
QA Validation Specialist
Validation & Technical Standards Specialist
Validation Analyst – Qualification section
Validation Specialist

Starting Salary: €40,000 to €45,000
After 2 Years: €45,000 to €60,000
After 5 Years: €60,000 to €75,000
Validation Engineer
Rigorously test and pre-test the systems used to manufacture products and create and document an evidence trail to show that the systems and equipment used, produce a defect-free consistent result. This is a more senior role.
Some companies might call this role:
CQV Engineer
Manager / Associate Manager – QA Validation
Mgr/ Snr Mgr QA Validation Oversight
QA Validation Engineer
Quality & Validation Engineer
Senior Validation Engineer
Senior Validation Specialist
Staff Engineer, Quality/Validation
Validation Scientist

Starting Salary: €39,000 to €50,000
After 2 Years: €45,000 to €60,000
After 5 Years: €60,000 to €100,000
Process Validation Engineer
This is generally considered an advanced role and requires thorough process knowledge and experience with process validation engineers working in engineering design, tech-transfer, upstream and downstream manufacturing. Most practitioners tend to have a lab/science, chemistry or chemical/process engineering background although or have learnt experientially on the job through extensive work experience.
Cleaning Validation Engineer
Design and develop cleaning procedures for new products and manufacturing equipment and also investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations for non validated or underdeveloped cleaning procedures. This is a highly specialised role requiring in-depth knowledge of chemical cleaning processes so most practitioners tend to have a lab/science, chemistry or chemical/process engineering background or have learnt experientially on the job through extensive work experience or on-the-job training.
Some companies might call this role:
Cleaning Validation Specialist
QA Validation Specialist – Cleaning Validation
QA Validation – Clean Hold Executor
Your 30-week class schedule


Module 1 – Pharmaceutical Facility Design
In this module, you will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpins an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.
Week 1 – Controlling Air Quality and Clean Utilities Part 1Week 2 - Controlling Air Quality and Clean Utilities Part 2Week 3 – Purified Water Generation and Distribution Part 1Week 4 – Purified Water Generation and Distribution Part 2Week 5 – Clean Steam and SterilizationWeek 6 – Controlling Material and Personnel FlowsWeek 7 – Aseptic Processing and Vial FillingWeek 8 – Controlling Cleanrooms and AutomationWeek 9 – Quality Systems for CleanroomsWeek 10 – Construction Lifecycle for New and Modified FacilitiesComplete the Following Activities & WorkshopsComplete an End of Module Assignment
Module 2 – Planning a Validation Strategy
This module will give you a broad understanding of how to develop a Validation Master Plan (VMP) for a typical product lifecycle and to prepare the Process Validation Protocol for presentation during a regulatory audit.
Week 11 – What’s new in Validation and in QualityWeek 12 – ISPE Guidance Documents and ASTM E2500Week 13 – Preparing for Process ValidationWeek 14 – The Quality Plan, Change Control and the Validation Master Plan (VMP)Week 15 – Process ValidationWeek 16 – The Process Validation ReportWeek 17 – Cleaning ValidationWeek 18 – Health & Safety at the Operator/Product InterfaceWeeks 19 & 20 - Complete an End of Module AssignmentComplete the Following Activities & Workshops
Module 3 – From URS to PQ – a Validation Project 
This is a workshop driven module where you will develop a P&ID and then back-engineer it into a URS (User Requirement Specification) which will be used to identify the key process measurements that will form the basis of the Performance Qualification (PQ) test script.
Week 21 to 22 – Supplementary Content: Generation of Piping and Instrumentation Diagrams, URS for Hot Detergent and Hot PUW Generation and Distribution Skid System, Equipment List, Instrument List (Incl. both an Attachment and Video Link), Inline Components List (Incl. both an Attachment and Video Link), Piping Line List (Incl. both an Attachment and Video Link), P&ID Instrument Identification (Incl. Video Link Only)
Week 23 – P&IDs
Week 24 – URS Matrix
Week 25 – Workshop
Week 26 – Workshop
Week 27 – Workshop
Week 28 – Workshop
Week 29 – PQ Template
Week 30 – PQ Template
University Accredited by Technological University Dublin (TU Dublin)
This CPD Certificate (Continuous Professional Development) is university-accredited by Technological University Dublin (TU Dublin), Ireland subject to the submission of all assessments and end-of-module assignments.
Level 7
Program Credits (ECTS): 15
Awarding Body: TU Dublin
Available Worldwide
This Pharmaceutical Validation Training Course (Certificate in eValidation) is available worldwide.
Hear from people who taken this program

Regina McNamara

“I can Study Around Work and Family Commitments”
I’d recommend this course to anyone that wants to work in the Pharmaceutical and Medical Device Manufacturing industry and is interested in building a successful career in this area. The online experience is working well for me as I study around work and family commitments.
The companies I applied for were very impressed. I am currently working in Boston Scientific manufacturing Balloon Catheters for Gallstone patients.

Mehmet Hascan

“Material was Delivered in an Engaging, Interesting and Supportive Way”
Having faced a career change in the middle of an economic downturn, I lost some of myself confidence and needed a major boost. The area of Biopharmaceutical operations and validation was of interest to me as it does play an important role in the pharmaceutical industry at present.
I have now been working at Johnson and Johnson Vision Care as a Validation Engineer and I look forward to putting what I have learned into practice.

Sharon Egan

“Structurally Well Planned with the Opportunity for Practical Application”
I found the course to be interesting, structurally well planned with the opportunity for practical application of the course modules through various assignments.
I have worked in the Medical device/Pharmaceutical and Food industries and found the course to be extremely relevant to all industries.
Read over 55 reviews and graduate success stories like these.
And delivered by industry experts



Dr. Joe Brady
Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled
Dr. Joe Brady is full-time practicing Validation Lead and an assistant lecturer with Technological University Dublin (TU Dublin), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer and highly experienced in competency-based training. He designs and prepares educational modules and full academic programs ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institution.
He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over twenty years of project experience in the pharmaceutical, biopharmaceutical, and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.



Professor Anne Greene
Senior Lecturer, Technological University Dublin
Professor Anne Greene is a Senior Lecturer in Pharmaceutical Technology, Validation and Pharmaceutical Quality Assurance to undergraduate and postgraduate students and a Pharmaceutical Projects Manager at Technological University Dublin, Ireland.
In addition, Anne is the Director of the Pharmaceutical Regulatory Science Team and is also secretary of the Parenteral Drug Association (PDA) Secretary, Irish Chapter. Her experience ranges from a technical service chemist, Sterling Wintrop Dungarvan, (now GSK), validation manager at startup Wyeth Newbridge, (now Pfizer) and is a Training Director at NIBIRT in Ireland.
If you’re spending money on an education program, make sure you choose one you’ll finish!
With every GetReskilled ONLINE program;
We use one centralized platform (Moodle) where you can log into your classroom anytime. Each week, you’ll watch videos and complete a series of quizzes, tests, interactive activities, and projects. The course materials are available 24/7 and nothing requires you to be online at a specific day or time. i.e there are NO ZOOM classes and NO WEBINARS! Study anywhere, anytime, for example after the kids have gone to bed or on the weekend.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
We release only one week’s worth of material at a time and then MANUALLY check your activity logs at the end of every week to make sure that you are keeping up with your work.
You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind. They will work with you to develop a study plan to get you back on schedule and finish the course.
This all helps us to spot any potential issues early and helps you completely finish the program.

Take our part-time online “Conversion Course into Pharmaceutical Manufacturing“
NO Previous Industry Experience or Science Qualifications Required

Pharmaceutical Validation Training Course (ONLINE)  – For More Senior Validation, CQV and C&Q Roles

1/10 Monthly Instalments

Only available if you’ve GMP Pharmaceutical Manufacturing Experience

Reduced Price After Skipping First 5 Weeks

START within 24 working hours upon receipt of payment. Complete this program in 15 days.

15 Day Fast Track Option

Average entry-level pharma roles pay 96% of NHS Band 5 and come with opportunities for overtime, shift allowance and additional benefits as well as huge scope for career progression and salary increases.
We have limited scholarship places available for outstanding HCPs to take our University Certificate in Pharmaceutical and Medicinal Product Manufacturing.
If you’ve been feeling increasingly stressed or burned out by your job in healthcare, you’re not alone.
A career in pharma manufacturing would let you take a step back from the stress of the frontline but allow you to keep making a positive impact on patients’ lives.
We know a career change is a big deal but with your background in healthcare, you’re already a great candidate for a career in pharma manufacturing.
And perhaps it’s not as much of a change as you think…
Scholarships Available for 10 outstanding HCPs
Entry-level pharma manufacturing salaries are 96% of NHS Band 5
Application Deadline: 16th July – Limited Places Still Available
Firstly, this is NOT a sales page. We are not interested in trying to convince you into signing up for our course if it’s something you’re not ready for.
This page is all about helping you to work through the things you need to think about so you can make an informed decision about whether returning to education is the right move for you, your career and your family right now.
There are 12 things you need to think about…
(you can click through to any of these sections at anytime you want)
Why healthcare professionals are great candidates for pharmaceutical manufacturing
The 15 second eligibility check
Scholarship opportunity
Job opportunities
The course – essential details
Finding a team you can trust
Why “online” increases your chance of success
Course syllabus
Reasons other people have made this change
Price
Gut check!
Next steps
So let’s get started….
Take Note!
The next course will be close for applications on Sunday 16th July
Classes start on 24th July
Apply Now
Call Sinead: +44 078 0237 0554
Psst! Because some people like to skip to the last page of a book without reading the whole story, here are the answers to your burning questions:

Course Content & Accreditation
You will complete 5 modules over 12 months, after which you will graduate with a Level 4 University Certificate from the University of South Wales

Programme Fees
The programme fees are payable in 12 instalments of £375 per month. (check point 9 for more details)

Scholarship Available
GetReskilled does have a Healthcare Professional Scholarship award (Limited Places)
(check point 3 for more details)
1 – Why healthcare professionals are great candidates for pharmaceutical manufacturing
Every drug your patients ever took and every medical device you’ve ever encountered in your role as a healthcare professional was manufactured by a team of people in a pharmaceutical or medical device manufacturing facility.
These people had to follow strict guidelines and protocols to make sure that the products they made were ultimately safe for your patients. They also go into work every day knowing that they’ll have a positive impact on patients’ lives.
Your work as a healthcare professional and their work manufacturing safe and effective medicines and devices is very closely linked.
Working in healthcare means you have demonstrable skills in using and following systems, processes and procedures to ensure patient safety. This is EXACTLY what pharmaceutical manufacturing requires.
You’ve been on the same team the whole time – “Team Patient” – you probably just hadn’t thought about it.
Your shared team is precisely the reason that healthcare professionals make great candidates for roles in pharmaceutical manufacturing.
So yes, this would be a career change. But you’re not leaving Team Patient – you’re just switching positions on the pitch.
You’d move away from the frontline, where you’re constantly playing catch up and trying to do too much with too few resources. And you’d move to a role without those stresses and strains.
Your role in the team becomes making sure that your frontline colleagues have everything they need, and that it can be relied upon to be safe and effective. You’re all still working together to make patients’ lives better.
2 – The 15 second eligibility check
You need to meet ONE of the following criteria:

A-Levels Level 3 Qualification or
Higher
You are eligible for the programme if you have your A-Levels, or a Level 3 qualification or anything higher
OR

GCSEs Level 2 Qualification & Relevant Experience
You are eligible if you have your GCSEs or any level 2 qualification, & you work in manufacturing, healthcare, science, engineering, validation etc.
OR

GetReskilled Conversion into Pharma Manufacturing Course
You are eligible if you have taken our Conversion Course into Pharma Manufacturing. Click here for more details on this programme
Please Note: For non-native English speakers, applicants may need to take a Duolingo, IELTS, TOFEL or equivalent language
test for this course. See the FAQ at the bottom of the page for more details
3 – Scholarship Opportunity
So now you know you’re a great fit for a career in pharma manufacturing.
But your skillset does need to be supplemented with some essential technical information used within the industry. That’s where our University Certificate in Pharmaceutical and Medicinal Product Manufacturing comes in.
Before we get into the details of the course and your job prospects in pharma, we want to get some cost concerns out of the way as we know many adult learners aren’t eligible for Government tuition funding.
This course typically costs £375/month for 12 months BUT for our June 2023 intake ONLY we’re offering 10 outstanding healthcare professionals a scholarship opportunity…
This is a 75% scholarship, meaning recipients will pay just £93 per month for 12 months.
This scholarship is only available for the course starting on the 24th of July 2023 (the application deadline for this is the 26th of July (2023).
Click here to leave your phone number and we’ll phone you back to talk about how to apply for one of our scholarship places
4 – Job opportunities in pharma manufacturing
This course will get you in the door of a Pharmaceutical or Medical Device company. You will be able to apply for entry-level roles in the Production Department (working with the machines to make the medicines or devices) or in the Quality Department (testing the medicines or devices to make sure they are safe for patients).
These roles are typically called Production Technicians or:
Production Operator
Manufacturing Technician
Packaging Operator
Product Assembler (depending on the specific role and the company)
According to the Office of National Statistics, the pay of average entry-level roles in pharma manufacturing is 96% of “NHS Band 5 with less than 2 years’ experience”. These roles come with opportunities for overtime, shift allowance and additional benefits as well as huge scope for career progression and salary increases.
But what does that really mean as a day-to-day job?
Well as pharma company, Baxter put it…
“This is where you save and sustain lives” as you “help with all day-to-day tasks of preparation and inspection of compounding medicine”.
From an entry-level role, you can progress into roles such as Team Leader, Supervisor, or even Head of Department.
As part of your course, you’ll learn a lot more about career paths through the industry.
5 – The Course – Essential Details
Our University Certificate in Pharmaceutical and Medicinal Product Manufacturing programme is a unique combination of technical modules and job hunting support that takes you from no industry knowledge to successfully starting your first job in pharma.
The practical details:
University Level 4 Certificate, accredited by the University of South Wales
Delivered entirely online
15 hours per week with a fully flexible timetable – there are no ZOOM classes or webinars so you decide when and where to study
11 months to complete
But you don’t have to wait for the academic year to start in September, our next class starts on July 3rd (applications close on July 16th)
6 – Finding a team you can trust
GetReskilled are a niche education company who specialise in helping people move into pharma manufacturing from other industries.
That’s all we do – so we’re really good at it.
We’ve won education awards, we’ve won pharma industry awards and we even placed 2nd in a European vocational training award. Our programmes are developed in conjunction with some of the world’s biggest pharma companies (including Pfizer and MSD) and they’re delivered by highly respected working industry professionals.
We don’t say that to brag.
We say it so you know that when you choose GetReskilled, you’re choosing a team and a programme that you can trust.
We’ve been doing this for 15 years and have trained over 5,000 people. We only take a select number of individuals into our programmes each year because we know that the key to your success is the individual attention you get before, during and after your studies with us.
We know every student’s name and we’re as invested in your success as you are.

7 – Why online with GetReskilled increases your chance of success
We do things a little differently at GetReskilled…
Single Point of Contact
We give every student a dedicated Programme Coordinator. They are your single point of contact throughout the course. Any questions about the programme, the technical information, or working in the industry – it all goes to them.
Personal Trainer
You’ll get one week of course materials released at a time and your Programme Coordinator will manually check your progress at the end of the week. Think of them like a personal trainer for your studies – if it ever looks like you’re starting to fall behind, your Programme Coordinator will reach out and help you put a plan in place for catching up and staying on track.
Online
Learning is 100% online and your study materials are available to you 24/7 – this means you can truly study at the time and place that best suits you. You don’t have to waste time commuting to a classroom and you can take advantage of even the smallest window of available time in your weekly schedule.
No Fixed Class Times
There are no fixed class times – you have the week to complete the topics that you’re given and it’s up to you when you fit that in. You don’t have to quit work, you don’t have to give up precious family time and you don’t need to rearrange any caring responsibilities or previous ongoing commitments.
Support Through Your Job Hunt
We know from over 15-years experience that when you’re changing careers, it’s not just about learning technical details. Figuring out how to successfully job hunt in a new industry takes time and effort. We decided that we’d save you all that uncertainty by creating a dedicated module that walks you step by step through the job hunting process. When we say we take you all the way from knowing nothing about the industry, to your first job – we mean it!
Imagine what having that level of support and accountability does for your chances of reaching your goals… we’re with you every step of the way.


8 – Course syllabus: University Certificate in Pharmaceutical and Medicinal Product Manufacturing
1) Fundamentals of Pharmaceutical Manufacturing Technologies
This will give you a broad understanding of current Good Manufacturing Practices (cGMPs) – this is the set of unique regulations that pharmaceutical and medical device manufacturers legally have to follow to make sure they’re making safe products. This is the baseline of knowledge that employers in this industry require employees to have.
2) Writing Skills Module
This module equips you with a high level of written communication skills. You’ll study this as you’re writing your end-of-module assignment for module 1. Not only will it walk you through the writing process for that (ensuring that you present your ideas in a way that gives you the best chance at achieving great marks), it’s also a highly practical development of the writing skills you’ll need for a role in the pharmaceutical or medical device industry.
3) Pharmaceutical Facility Design
This will give you a strong grounding in the unique utility systems (e.g. air and water) that are used in a manufacturing facility and the quality systems that are used to make sure that products are safe and effective. Being able to confidently talk about these concepts will definitely impress employers and set you apart from other candidates.
4) Job Hunting Skills
This second skills module is the one that really gives your pharma job hunt a boost. We’ll walk you through the pharma job hunting process step-by-step, showing you the types of jobs to consider, how to really catch an employer’s attention with your application, and how to confidently interview within this industry. As soon as you’re finished this module, you can put it into practice and start making applications
5) Fundamentals of Chemistry for the Pharmaceutical Industry
This final module will give you a foundation in the general chemistry you’ll need to understand for the manufacture of medicinal products.
(But please note, you don’t need any previous science qualifications or experience to take this course or get a job in pharmaceutical manufacturing).
9 – Reasons other people have made this change
People come to us for a variety of reasons:
They want to equip themselves with the skills, qualifications or knowledge to change careers
They are feeling burned out in their current job. We’re seeing this a lot with healthcare workers right now – they’re telling us that they want to help patients but need to take a step back from the frontline in order to continue do so
They want to get a university qualification, after years of thinking that university isn’t for them (usually because they haven’t found a place where their specific needs are met)
They’ve taken a break from the workforce to care for their families and are now in a place where they can put their needs, wants and careers first again
They don’t feel valued or fulfilled at their current job. They want something that makes them feel like they are helping people and contributing to society
They want a well-paid job that has opportunities for their career to advance, all while getting paid a good salary for their time and effort
They see their friends and family loving their jobs and being excited to go to work each day, and want the same for themselves
Does any of this sound familiar? Try to put into one sentence what is happening in your life right now that makes this the right move for you, your family and your career.
Write it in the box below, and maybe for the first time ever, make it real to yourself what you want.

10 – Course Fees
Many adult learners want to return to education but find it difficult because they aren’t eligible for the Government’s Repayable Tuition Loan.
To help make our programmes accessible to as many people as possible, we operate an interest-free monthly payment plan. Total course fees are spread across the 12 months of study with no additional fees or charges.
This means you don’t have to pay all your fees upfront and you won’t have any debt hanging over you when you’re finished!

£375/month for 12 months
Or £93/month for 12 months for scholarship recipients
Price Includes:
End of week progress checks by us to MAKE SURE you finish the course
University accreditation by University of South Wales, UK
Delivered online so you can learn from home (or anywhere) on your own schedule
Robust job hunting skills course that will seriously help you find a job
Regular & ongoing access to a dedicated career coaching counsellor
No Hidden Fees
No application fees
No registration fees
No resource/book fees
No certificate fees
No interest fees
11 – Gut Check!
So, Gut Feeling – Yes or No…
Which button are you clicking?
12 – Next Steps!
The application process is as follows:
You can request more information about the programme – you can receive this via email or you can fill in your details and a member of the team will phone you to talk through you suitability and answer any questions you might have (click the button on the computer or the phone for these choices)
Once you’re sure this is the right decision for you, you’ll submit registration documentation (NOTE: if you’re already convinced, press the final big red button below and you’ll be taken straight to the registration form)
When we receive your registration form, we will review your submission and follow up, offering interviews after the application date has passed (16th July)
You will then complete both a written and telephone interview
Once the interviews are concluded, offers will be sent out. Successful candidates will have 24 hours to accept their offer
The course will then begin on 24th July

Average entry-level pharma roles pay 96% of NHS Band 5 and come with opportunities for overtime, shift allowance and additional benefits as well as huge scope for career progression and salary increases.

Retrain ONLINE for a Higher-Paying Job in the Pharma Manufacturing Industry in 10-Weeks

1/12 Monthly Instalments

Take this 2-module program including “Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems”. Learn to read P&IDs. Learn how to populate a 120-page plus IQ OQ PQ Protocol and qualify equipment and systems. Developed in consultation with the pharma industry including Pfizer and MSD.
Build on your industry experience and start a higher-paying career in validation
Turn your practical work experience into an advanced certification
Estimated salaries €39,000 – €70,000 plus overtime, bonuses and allowances. (Based on Irish job data)
Application Deadline: Wednesday 19th July
Study Online part-time
12hrs/week for 15 Weeks or choose the 15-Day Fast Track Option
You’ll get a dedicated course leader who’ll check your progress at the end of every single week and follow up with you to help you finish the course
Join 2340 Learners
Core content developed on a pharma construction project
This program was developed on-site by a team of senior chemical engineers, validation engineers, and biochemists working within an engineering consultancy during the construction of a new pharmaceutical plant to train its own engineers and technicians.
Learn how to fill out a 120-page plus IQ OQ PQ protocol
We will walk you through this step-by-step process and teach you how to populate a blank IQ OQ PQ template to qualify a Clean-in-Place System. The blank template is taken from the construction site of a pharmaceutical plant.
This is a fundamental skill for any validation professional and a key outcome for this program. You will be able to take this completed and substantial document to any job interview and demonstrate your ability to complete this task.


Minimum Entry Requirements
This program is highly specialized so you MUST have one of the following:
You are a plumber/pipefitter/pipe welder (e.g. high purity pipe fitter and orbital welder) / instrument technician (i.e. you can interpret technical drawings, especially P&IDs and pipe skids) and you are fed up working outside on freezing cold construction sites.
Or
You have GMP manufacturing experience or have a recognized GMP qualification.
Or
You have commissioning & qualification experience in ANY INDUSTRY e.g. Oil and Gas, Food Manufacturing, etc.
Or
You work in Quality Assurance or Quality Control in the pharma industry and are worried about having to sign off on validation documents you don’t fully understand!
Or
You are a chemical / process / petroleum / project / mechanical, etc engineer or a laboratory scientist and want to move into a validation role or learn how to correctly populate an equipment validation protocol.
Or
You already work in validation (e.g. mechanical contracting company carrying out high-purity pipework installations) but have no formal training on IQ OQ PQ equipment qualification protocols.




Our learners work for the world’s biggest pharma and medical device companies



































What validation, CQV and C&Q roles could I retrain for?
STEP 1, you take this “Equipment Validation Course” to retrain for the following roles;
Validation Technician – Some pharma companies call this role:Associate QA Validation SpecialistEquipment Validation SpecialistQA Validation AssociateQA Validation Specialist
CQV Specialist – Some pharma companies call this role:CQV Junior EngineerC&Q SpecialistC&Q Junior Project Manager
With validation, CQV and C&Q roles, you could work directly for:
pharmaceutical companies on in-house projects
engineering consultancies as part of a project team on small to large capital projects
engineering contractors as part of a project team on small to large capital projects
View Salaries
STEP 2, then take our Pharmaceutical Validation Training Course – For Senior Validation Roles to get a level 7 university accredited “Certificate in Validation” from Technological University Dublin, Ireland and a more interesting job with a higher salary such as:
Validation Engineer
CQV Engineer
Senior Validation Specialist
C&Q Technician
STEP 3, take our Computer System Validation Course and extend your role to CSV projects. Round out your qualifications and give yourself a competitive edge in the marketplace.




Enroll in this program to learn…
How to prioritise which parts of the equipment system are critical to validate and which parts are not etc, using component impact assessments and risk management tools.
How to read/interpret the engineering documentation such as P&IDs, Piping Isometrics & Electrical Loop Drawings used to define the equipment system.
How the intent of a process (like maintaining the product at the required temperature) is linked to the equipment that will be used to do this.
The tests along with the functional test scripts necessary to confirm that the installed equipment is fit-for-purpose, i.e. that it will do what it states that it will do based on the User Requirement Specifications).
How to use a traceability matrix tool to ensure that all requirements defined within the User Requirement Specifications (URS) are tested in the protocol.
How to qualify equipment, instruments and piping systems, and automation controls.
How to document all of these steps in a 100 page plus equipment validation protocol which you will develop as your end of module assignment.
You’ll produce a number of deliverables throughout the program including…
Complete 2 Quality Risk Management workshops on:Fault Tree Analysis (FTA)Failure Mode Effect Analysis (FMEA)
Complete 5 Equipment Qualification Protocol workshops on the following to prepare you to populate your own protocol:Component Level Impact AssessmentEquipment Installation VerificationPiping Installation VerificationInstrument Installation VerificationFunctional Verification Test
Complete 12-question booklets (one for every week’s worth of content) which will summarise what you have learned for the week and ensure you retain and understand the information.
Populate a 120-page plus IQ OQ PQ protocol
The end of the module assignment and key outcome for the program will be for you to populate an IQ OQ PQ protocol for a clean-in place-system. The protocol will detail the following elements;
Product characteristics – showing what your system is looking to achieve/produce
Production equipment – detailing the equipment necessary
Test scripts and methods – telling you the steps involved in conducting a test
Test parameters and acceptance criteria – defining acceptable test results
Test checksheets – documenting and recording the test results
Final approval – documenting that the validation process has been successfully carried out
Complete 2 modules over 15-weeks
Module 1 – Manufacturing Safe Medicines and Medical Devices (GMP) (Weeks 1-5)
In this module, you’ll learn about the systems used in pharmaceutical manufacturing. You’ll learn about the rules and regulations such as Good Manufacturing Practices (GMPs) that you need to follow. And you’ll learn enough technical information to get you talking to employers.
Module 2 – Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems (Weeks 6-15)
In this module, you will develop your own 120-page Qualification Protocol to qualify a clean-in-place system. You will also learn to read P&IDs, Piping Isometrics & Electrical Loop Drawings used to develop qualification protocols. And you’ll learn how to qualify equipment, instruments and piping systems, along with automation controls and building facilities.
View Full 15 Week Syllabus
Already have equipment qualification experience?
If you already have some experience working in Validation and know how to populate an IQ OQ PQ equipment qualification protocol, check out our academically accredited Pharmaceutical Validation Training Course – For Senior Validation Roles.




So what is validation?
Pharmaceutical Validation creates a documented evidence trail (through rigorously checking and testing) to demonstrate that equipment, a system, procedure or process used in the production and testing of the pharmaceutical product:
maintains compliance at all stages
and leads to a consistent and reproducible result
There are many other definitions of validation but the essence of all these definitions seems to be “documented scientific proof of consistent performance“.
Qualification is one part of a validation process for making sure that a facility – and the equipment in it – will function as required and be approved by the regulatory agencies that have jurisdiction over that facility.
An Equipment Qualification Protocol is a written plan stating how qualification will be conducted including test parameters, product characteristics, production equipment and decision points on what constitutes an acceptable result.
IQ OQ PQ or Installation Qualification, Operational Qualification, and Performance Qualification are 3 independent and documented procedures used together (when executing a qualification protocol) to check and test that a mechanical or software system is;
installed correctly
meets its design requirements and specifications
operates the way in which it was designed under load
Need more detailed information?
Commissioning vs Qualification vs Validation
What are IQ OQ PQ?
What is an Equipment Validation Protocol?
IQ, OQ PQ Templates


Watch this video on a validation engineer’s role!
For a great insight into validation roles from someone actually in the job, check out this video from the About Bioscience website, produced by the North Carolina Association for Biomedical Research (NCABR).



Hear from people who’ve taken this equipment qualification course



Colin Lane
Previous background:
Med device manufacturing



“Validation – A career move to tell your friends about”
“I would say to anybody out there, if you’re thinking about doing this validation course, just go for it. Do it.
There’s a great opportunity within the course to learn. There’s a lot of detail about what goes on in the industry, on the floor, how things happen. Focus just as much on learning to actually educate yourself as much as passing exams. You actually have to embrace it and really get interested in the course material.
Hear more and read how Colin moved from medical device manufacturing into validation.



Charles O Neill
Previous background: Pipefitter/Plumber



“With hard work and determination, you can achieve your goal”
“As a pipefitter/Plumber who worked within the pharmaceutical industry for the last 20yrs, this program gave me the tools I required for a career change and to upskill for a job in pharmaceutical manufacturing. Without this course, I don’t think I would have achieved this. I am happy to say that I have been successful in my employment search.
It is worth the challenge and with hard work and determination, you can achieve your goal.
It gave me a better understanding of pharmaceutical protocols and how the pharmaceutical industry works as a whole.”



Regina McNamara
Previous background:
Professional Painter



“I can study around work and family commitments”
Studying online is working well for me as I study around work and family commitments.
I would recommend this course to anyone that wants a new career in the Pharmaceutical and Medical Device Manufacturing industry.


Your 10 or 15 week class schedule 
Note: If you’ve worked in a GMP Regulated Pharmaceutical Manufacturing Environment, you are exempt from the first 5 weeks (Module 1) of the program. You also get a price reduction. 
15-Day Fast Track Option Available – For an additional cost, you can request an immediate start and complete the 2-module 15-week program in 15 days. This is going to be tough but your course leader will check your progress every morning and follow up with you to keep you on schedule. START within 24 working hours upon receipt of payment.
Download Brochure


Module 1 – Manufacturing Safe Medicines and Medical Devices (GMP) (Weeks 1-5)
Week 1 – Industry Regulations and GuidelinesWeek 2 – Process Validation & Documentation and Risk Management ToolsWeek 3 – Key Manufacturing TechnologiesWeek 4 – Supporting Technologies and CleanroomsWeek 5 – Assignment Part 1 focussed on GMP Manufacturing from content in Week’s 1-4






Module 2 – Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems (Weeks 6-15)
This module was developed in consultation with the pharma industry including Pfizer and MSD.
Week 6 – Interpreting P&ID’sWeek 7 – System Impact Assessment & Traceability MatrixWeek 8 – Installation Tests & Equipment VerificationWeek 9 – Piping Isometrics & ChecksheetsWeek 10 – Instrument Loops & ChecksheetsWeek 11 – URS & Functional TestingWeek 12 – Assembling the Validation ProtocolWeek 13 – Validation Protocol Final ReviewWeeks 14 -15 – Complete an End of Module AssignmentComplete the Following Activities and WorkshopsCertified by GetReskilled


Delivered by a practicing industry expert



Dr. Joe Brady






Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled
Dr. Joe Brady is a full-time practicing Validation Lead and an assistant lecturer with Technological University Dublin (TU Dublin), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer and highly experienced in competency-based training. He designs and prepares educational modules and full academic programs ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institutions.
He is also a supervisor for MSc/MEngSc and Ph.D. theses. Joe has over twenty years of project experience in the pharmaceutical, biopharmaceutical, and medical device industries in Ireland, Singapore, China, The Netherlands, France, and the USA.


Hear from people who’ve taken this equipment qualification course



Mehmet Hascan
Previous background:
Technical Support



“Material was delivered in an engaging, interesting and supportive way”
The administration staff and lecturers at Getreskilled are first class and the course material was delivered in an engaging, interesting and supportive way.
I have now been working at Johnson and Johnson Vision Care as Validation Engineer in Limerick and I look forward to put what I have learned into practice.



Sharon Egan
Previous background:
Food Manufacturing



“Structurally well planned with the opportunity for practical application”
I found it to be interesting, structurally well planned with the opportunity for practical application of the course modules through various assignments.
I have worked in the Medical Device/Pharmaceutical and Food industries and found the course to be extremely relevant to all industries.


Start your application
Apply NOW and retrain for entry-level Validation, CQV and C&Q roles


Talk to our team
USA/World
Call: +1 (617) 901 9268
Ireland
Call Geraldine: +353 (0)21 2409016


If you’re spending money on an education program, make sure you choose one you’ll finish!
With every GetReskilled ONLINE program;
We use one centralized platform (Moodle) where you can log into your classroom anytime. Each week, you’ll watch videos and complete a series of quizzes, tests, interactive activities, and projects. The course materials are available 24/7 and nothing requires you to be online at a specific day or time. i.e there are NO ZOOM classes and NO WEBINARS! Study anywhere, anytime, for example after the kids have gone to bed or on the weekend.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
We release only one week’s worth of material at a time and then MANUALLY check your activity logs at the end of every week to make sure that you are keeping up with your work.
You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind. They will work with you to develop a study plan to get you back on schedule and finish the course.
This all helps us to spot any potential issues early and helps you completely finish the program.





Earn a Certificate of Award in “Commissioning & Qualification of Equipment and Systems”
Earn by successfully populating a 120-page IQ OQ PQ template to qualify a Clean-in-Place System and get a Certificate of Award in Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems.
Add details of your certificate to your CV/Resume or your LinkedIn profile.






Educators providing Medical Device Development courses delivered On Demand