25 Courses

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Course Information Designed to develop personal proficiency in audit planning, execution and reporting, this course is meticulously crafted to refine essential audit skill sets. Through immersive scenarios focused on on-site audit conduct (with an alternative Remote Auditing Course available), participants will engage deeply in the audit process. Extending Expertise: Applicable across all audit types, this course builds upon and enriches the foundational concepts taught in RQA's suite of research quality assurance courses. From 'Research Quality Assurance for Good Laboratory Practice' to 'Good Clinical Practice Auditing – Principles and Practice' and 'Good Manufacturing Practice for Investigational Medicinal Products,' this programme extends the scope of learning. Relevance and Value: Relevant to any area of regulated research and development, this course shines particularly in contexts mandating a quality system for audit. Participants with prior audit experience will gain maximum value from this course.  Key Benefits: Enrich your skill set to: Navigate audit processes encompassing planning, execution, reporting, and follow-up Embrace a personalised approach fostering positive audit outcomes Analyse evidence and present cohesive audit findings Recognise the pivotal role of audits in driving continual improvement. Interactive Learning: Structured to foster dynamic engagement, this course encourages delegates to: Engage in discussions, idea development, and problem-solving Exchange invaluable information and experiences. Hands-On Experience: A highlight of this course is the series of practical workshops, where delegates work in small syndicate groups, applying the acquired skills from lectures into real-world scenarios. Tutors Tutors will be comprised of (click the photos for biographies): Andrew Waddell Founder Director, Tower Mains Ltd Rosemary Ichaba Senior QA Associate, Tower Mains Ltd Cate Ovington Director, The Knowlogy Group Ltd Jean McWilliam Associate Director, Alexion View pop up Programme Please note timings may be subject to alteration. Day 1 08:45 Registration 09:00 Welcome and Course Objectives 09:10 What is 'Audit'? Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements. 09:30 Audits and their Purpose The concepts of quality assurance, quality control, quality management and audit are discussed. 10:30 Break 10:45 Audit Planning The requirements for an effective audit programme and individual audit plans. 11:30 Workshop 1 - Getting the Audit Started Planning for the audit. 12:25 Workshop 1 - Feedback 12:45 Lunch 13:30 Workshop 2 - Getting the Audit Started Arranging the opening meeting. 13:50 Workshop 2 - Feedback Audit initiation. Review and discussion of the role of the opening meeting. 14:25 Auditing Techniques (1) - Data and Documentation Techniques for the conduct of data and report audits are investigated. 14:55 Break 15:10 Workshop 3 - Data and Documentation Audit Conducting an audit of a data package and supporting documentation. 17:15 Close of Day Day 2 09:00 Auditing Techniques (2) - The People Questioning techniques which get the required information from the auditee. 09:45 Live Audit Role Play Auditor and auditee behaviours are explored and strategies developed for successful audit interactions. 10:15 Break 10:35 Audit Closing Meeting An exploration of audit closing meetings. 11:00 Workshop 4 - Audit Observations and Preparing for the Closing Meeting Reviewing and categorising your observations and getting ready to present your case. 11:45 Workshop 4 - Feedback 12:30 Audit Reports The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed. 13:00 Lunch 13:45 Workshop 5 - Audit Reports and Follow-up Mechanisms for promoting effective corrective and preventive action. Critical review of an audit report example. 14:30 Workshop 5 - Feedback 14:55 Corrective and Preventive Action and Follow-up The auditor's role in monitoring responses to audit and the corrective and preventive actions promised is explored. 15:20 Panel Session An opportunity to get answers to outstanding questions. 15:30 Close of Course Extra Information Course material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. CPD Points 14 Points   Development Level Develop

Ensure the utmost safety and compliance in your workplace with our 'Comprehensive Safety Audits: Ensuring Workplace Safety and Compliance' program. Dive deep into a systematic review of all processes, equipments, and protocols with a keen focus on Safety Audits. This course is meticulously designed to equip you with the knowledge and tools to identify vulnerabilities, make informed decisions, and fortify your work environment against potential hazards. Empower your organization to not just meet but exceed safety standards, because when it comes to safety, a comprehensive Safety Audit is your best line of defense.   Learning Outcomes: Understand the fundamentals of safety audits and their importance. Develop effective safety audit plans tailored to specific workplaces. Conduct comprehensive safety audits, identifying potential hazards and compliance gaps. Implement corrective actions and follow-up procedures to ensure workplace safety. Foster a safety-oriented culture and drive continuous improvement initiatives. Apply advanced safety audit methodologies and tools. Perform risk assessments to proactively address safety challenges. Interpret audit findings to make informed decisions for safety enhancement.   Why buy this Comprehensive Safety Audits: Ensuring Workplace Safety and Compliance?  Unlimited access to the course for forever Digital Certificate, Transcript, student ID all included in the price Absolutely no hidden fees Directly receive CPD accredited qualifications after course completion Receive one to one assistance on every weekday from professionals Immediately receive the PDF certificate after passing Receive the original copies of your certificate and transcript on the next working day Easily learn the skills and knowledge from the comfort of your home   Certification After studying the course materials of the Comprehensive Safety Audits: Ensuring Workplace Safety and Compliance you will be able to take the MCQ test that will assess your knowledge. After successfully passing the test you will be able to claim the pdf certificate for £5.99. Original Hard Copy certificates need to be ordered at an additional cost of £9.60.   Who is this Comprehensive Safety Audits: Ensuring Workplace Safety and Compliance course for? Safety and Compliance Officers. Workplace Health and Safety Managers. Quality Assurance and Control Professionals. Environmental Health Specialists. Managers and Supervisors responsible for workplace safety. Anyone interested in pursuing a career in workplace safety and compliance.   Prerequisites This Comprehensive Safety Audits: Ensuring Workplace Safety and Compliance 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.   Career path   Safety Compliance Officer: £30,000 - £50,000 per year. Health and Safety Manager: £35,000 - £60,000 per year. Quality Assurance Manager: £40,000 - £70,000 per year. Environmental Health Specialist: £30,000 - £50,000 per year. Safety Auditor: £35,000 - £55,000 per year. Course Curriculum Module 01: Introduction to Safety Audit Introduction to Safety Audit 00:24:00 Module 02: Safety Audit Planning Safety Audit Planning 00:19:00 Module 03: Conducting Safety Audits Conducting Safety Audits 00:20:00 Module 04: Corrective Actions and Follow-up Corrective Actions and Follow-up 00:14:00 Module 05: Safety Culture and Continuous Improvement Safety Culture and Continuous Improvement 00:14:00 Module 06: Advanced Safety Audits Advanced Safety Audits 00:21:00 Module 07: Risk Assssment Risk Assssment 00:15:00 Module 08: COSHH COSHH 00:18:00

ISO 30401 sets requirements and provides guidelines for establishing, implementing, maintaining, reviewing and improving an effective management system for knowledge management in organizations. All the requirements of this standard are applicable to any organization, regardless of its type or size, or the products and services it provides. Knowledge management is the intentional process of defining, structuring, retaining, and sharing an organization’s employees’ knowledge and experience.

This course delves into the theoretical underpinnings of safety audit practices, from meticulous planning to advanced risk assessment and continuous improvement strategies.

Free Level 5 QLS Endorsed Certificate | CPD Accredited | 150 CPD Points | Advanced Learning Materials | Lifetime Access

Course Information Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. Apply risk management techniques to audit planning Plan and conduct computerised system audits Assess system validation documentation to verify compliance Evaluate data integrity and security issues Prepare for regulatory inspection. The course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Understand the vulnerabilities of computerised systems Learn how to create a compliance checklist Link system development with good business practice. Is this course for you? Auditors Audit programme managers Individuals subject to audits. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:45 Why We Validate and Regulatory Trends 10:30 Break 10:45 Audit Overview, High Level Process and Scheduling 11:30 System Lifecycle 12:30 Lunch 13:15 Exercise 1 - Audit Scheduling 14:45 Exercise 1 - Feedback 15:15 Break 15:30 Validation Deliverables 16:30 Risk Assessments 17:30 Close of Day 1 Day 2 09:00 Supplier Assessment 10:30 Break 10:45 Exercise 2 - Planning a Supplier Audit 12:00 Exercise 2 - Feedback 12:30 Lunch 13:15 Exercise 3 - Auditing a Computerised System Validation Package 15:30 Break 15:45 Exercise 3 - Feedback 16:30 Change Control 17:15 Close of Day Day 3 09:00 Infrastructure Qualification 09:45 Maintaining a Validated State - Operational Processes 11:00 Break 11:15 Exercise 4 - Auditing Systems in Operational Use 12:45 Lunch 13:30 Exercise 4 - Feedback 14:15 Exercise 5 - Auditing Trail Review 15:30 Break 15:45 Exercise 5 - Feedback 16:15 Course Objectives Summary and Any Additional Questions 16:45 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 19 Points Development Level Develop

Do you want to acquire the knowledge that will Help you Understand & Cope with your Asperger's Child? Asperger's syndrome is a developmental disorder that affects a child's ability to socialise and communicate effectively with others. Children with Asperger's syndrome typically present social awkwardness and an all-absorbing interest in specific topics. This course is designed for people who are caregivers for autistic individuals (Parents and Educators). This course aims to help you comprehend the world of Asperger's syndrome, spot the signs and symptoms of the syndrome spectrum so that you can help someone living with such a condition to live a richer life. Course Highlights Asperger Syndrome Awareness is an award winning and the best selling course that has been given the CPD Certification & IAO accreditation. It is the most suitable course anyone looking to work in this or relevant sector. It is considered one of the perfect courses in the UK that can help students/learners to get familiar with the topic and gain necessary skills to perform well in this field. We have packed Asperger Syndrome Awareness into 6 modules for teaching you everything you need to become successful in this profession. To provide you ease of access, this course is designed for both part-time and full-time students. You can become accredited in just 2 hours, 29 minutes and it is also possible to study at your own pace. We have experienced tutors who will help you throughout the comprehensive syllabus of this course and answer all your queries through email. For further clarification, you will be able to recognize your qualification by checking the validity from our dedicated website. Why You Should Choose Asperger Syndrome Awareness Lifetime access to the course No hidden fees or exam charges CPD Accredited certification on successful completion Full Tutor support on weekdays (Monday - Friday) Efficient exam system, assessment and instant results Download Printable PDF certificate immediately after completion Obtain the original print copy of your certificate, dispatch the next working day for as little as £9. Improve your chance of gaining professional skills and better earning potential. Who is this Course for? Asperger Syndrome Awareness is CPD certified and IAO accredited. This makes it perfect for anyone trying to learn potential professional skills. As there is no experience and qualification required for this course, it is available for all students from any academic backgrounds. Requirements Our Asperger Syndrome Awareness is fully compatible with any kind of device. Whether you are using Windows computer, Mac, smartphones or tablets, you will get the same experience while learning. Besides that, you will be able to access the course with any kind of internet connection from anywhere at any time without any kind of limitation. Career Path You will be ready to enter the relevant job market after completing this course. You will be able to gain necessary knowledge and skills required to succeed in this sector. All our Diplomas' are CPD and IAO accredited so you will be able to stand out in the crowd by adding our qualifications to your CV and Resume. Safety Audits Module 01: Introduction to Safety Audit 00:24:00 Module 02: Safety Audit Planning 00:19:00 Module 03: Conducting Safety Audits 00:20:00 Module 04: Corrective Actions and Follow-up 00:14:00 Module 05: Safety Culture and Continuous Improvement 00:18:00 Module 06: Advanced Safety Audits 00:21:00 Module 07: Risk Assssment 00:15:00 Module 08: COSHH 00:18:00

Duration 4 Days 24 CPD hours This course is intended for IS Security Officers IS Managers Risk Managers IS Systems Auditors Information Systems Owners IS Control Assessors System Managers Government Employees Overview Upon completion, Certified Information Systems Security Auditor students will be able to establish industry acceptable Cyber Security & IS management standards with current best practices and be prepared to competently take the C)ISSA exam. The Certified Information Systems Security Auditor, C)ISSA , course covers the skills and knowledge to assess vulnerabilities, report on compliance and implement controls for private and public enterprises. Many organizations require an Information System Auditor?s expert knowledge when it comes to identifying critical issues and providing effective auditing solutions. Through the use of a risk-based approach, the C)ISSA is able to implement and maintain cost-effective security controls that are closely aligned with both business and industry standards. Course Outline The Process of Auditing Information Systems Risk-Based Auditing Audit Planning and Performance IS Systems Auditor reports IT Governance and Management Systems Acquisition, Development and Implementation Systems Development Models Types of Specialized Business Applications Application Controls Information Systems Operations, Maintenance, and Support System and Communications Hardware Additional course details: Nexus Humans C)ISSA Certified Information Systems Security Auditor Mile 2 training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the C)ISSA Certified Information Systems Security Auditor Mile 2 course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.

Enhance your auditing expertise with our ISO 19011 Lead Auditor Course, covering management system auditing principles, ISO 9001:2015 clauses, and auditor competence evaluation. Become a proficient lead auditor and drive organizational improvement. Enroll now!