GxP courses in Sheffield

This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).

This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).

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.

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.

Course Information Join our comprehensive three-day training programme tailored for individuals seeking a foundational grasp of computerised system validation. This course equips participants with essential knowledge to effectively validate systems within their respective organisations for utilisation in GxP (GLP, GCP, GMP, GDP, and GPvP) environments. Attendees will also gain proficiency in auditing validated computerised systems, ensuring compliance with pertinent GxP regulations. Commencing with an overview of regulatory prerequisites and the system life cycle, the course transitions into practical aspects, centered around validating computerised systems and conducting subsequent audits. Engage in a dynamic blend of presentations, interactive discussions, and hands-on practical workshops throughout the course. This course will provide delegates with an understanding of the computerised system validation process, including: Definition of end user requirements Risk management, including supplier assessment and techniques for audit planning Validation planning and reporting Linking system development with good business practices Formal testing and qualification Understanding of data integrity and security issues How to assess system validation documentation to verify compliance. Is this course for you? IT professionals new to implementing computerised systems into regulated environments Quality professionals who monitor or audit computerised systems System owners, end users, tester and project staff. 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, Introduction and Course Objectives 09:45 Why Validate? Regulations and Guidance on Computerised System Validation Overview of the regulations and guidance applicable to CSV and their key expectations. 10:30 Break 10:45 The System Lifecycle The concept of the SLC and the key outputs from it. 12:00 Lunch 12:45 The Validation Process The approach to validation for different system types and a look at some of the key deliverables. 14:00 Project Introduction 14:15 Exercise 1 - User Requirements Capturing, agreeing and documenting the user requirements for a system. 15:15 Break 15:30 Exercise 1 - Feedback 16:00 Risk Management Risk management and its impact on validation. Identifying the deliverables required. Then group discussion on risk assessment for three systems. 17:00 Questions and Answers Answers to any outstanding questions from Day 1. 17:15 Close of Day Day 2 09:00 Supplier Assessment The different approaches to supplier assessment and the things to be considered when assessing a supplier. 10:15 Exercise 2 - Supplier Assessment Planning a vendor audit with a focus on the key validation deliverables. 11:00 Break 11:15 Exercise 2 - Feedback 11:45 Test Overview and Test Planning The different test phases, the purpose of each test phase and things to be considered when planning and reporting testing. 12:45 Lunch 13:30 Test Overview and Test Planning Continued. 14:15 Test Script Design, Execution and Review What a good test script looks like and the key things to consider when creating, executing and reviewing a test script. 15:30 Break 15:45 Exercise 3 - Creating a Test Script Create a test script based on user requirements created on Day 1. 17:15 Close of Day Day 3 09:00 Exercise 3 Feedback 09:30 Infrastructure Configuration and Qualification 10:30 Break 10:45 Validation Reporting Overview of the Validation Report and what should be included in it. 11:15 Maintaining the Validated State The procedures and records needed to ensure the system remains fit for purpose. 12:30 Lunch 13:15 Change Control Key concepts related to making changes to validated systems. 14:00 Data Integrity and Security How can we assure the integrity and security of our data. 15:15 Break 15:30 Course Objectives Summary and Panel Discussion A round up of key learning from the course. 17:00 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

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

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Overview Good manufacturing practices are essential in maintaining the standards of products. In various industries, these particles are used to deliver safe and high-quality products. You can learn the essentials of GMP and develop the ability to apply them with our exclusive Good Manufacturing Practice Training course. This online training is divided into easy-to-follow modules. From the modules, you will learn the fundamentals of GMP and safety regulations. Then the course will educate you on bad and good practices. Furthermore, you will learn the process of preventing and controlling contamination. The course will also include lessons on GMP in different industries. Along with the skill set you will also receive a certificate of achievement. This certificate will add significant value to your resume and increase your employability. Enrol now! Course Preview Learning Outcomes Understand the basic concepts of GMP and safety regulations Identify the differences between good and bad manufacturing practices Build your skills in controlling and preventing contamination Enhance your knowledge of maintenance and hygiene Learn about GMP in different industries Why Take This Course From John Academy? Affordable, well-structured and high-quality e-learning study materials Meticulously crafted engaging and informative tutorial videos and materials Efficient exam systems for the assessment and instant result Earn UK & internationally recognised accredited qualification Easily access the course content on mobile, tablet, or desktop from anywhere, anytime Excellent career advancement opportunities Get 24/7 student support via email What Skills Will You Learn from This Course? GMP Who Should Take This Good Manufacturing Practice Training? Whether you're an existing practitioner or an aspiring professional, this course is an ideal training opportunity. It will elevate your expertise and boost your CV with key skills and a recognised qualification attesting to your knowledge. Are There Any Entry Requirements? This Good Manufacturing Practice Training is available to all learners of all academic backgrounds. But learners should be aged 16 or over to undertake the qualification. And a good understanding of the English language, numeracy, and ICT will be helpful. Good Manufacturing Practice Training Certification After completing and passing the Good Manufacturing Practice Training successfully, you will be able to obtain a Recognised Certificate of Achievement. Learners can obtain the certificate in hard copy at £14.99 or PDF format at £11.99. Career Path​ This exclusive Good Manufacturing Practice Training will equip you with effective skills and abilities and help you explore career paths such as  Production Manager Quality Controller Compliance Officer Supply Chain Manager Quality Assurance Manager Module 01: Basic Concept of GMP and Safety Regulations Basic Concept of GMP and Safety Regulations 00:39:00 Module 02: Good and Bad Manufacturing Practice Good and Bad Manufacturing Practice 00:42:00 Module 03: Preventing and Controlling Contamination Preventing and Controlling Contamination 00:35:00 Module 04: Maintenance and Hygiene Maintenance and Hygiene 00:39:00 Module 05: GMP for Pharmaceutical Industry GMP for Pharmaceutical Industry 00:54:00 Module 06: GMP for Food Industry GMP for Food Industry 00:32:00 Module 07: GMP for Cosmetics Industry GMP for Cosmetics Industry 00:52:00 Module 08: IT Applications on GMP IT Applications on GMP 00:29:00 Assignment Assignment - Good Manufacturing Practice 00:00:00 Order Your Certificate and Transcript Order Your Certificates and Transcripts 00:00:00

Overview This comprehensive course on Good Manufacturing Practice (GMP) will deepen your understanding on this topic. After successful completion of this course you can acquire the required skills in this sector. This Good Manufacturing Practice (GMP) comes with accredited certification from CPD, 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 Good Manufacturing Practice (GMP). It is available to all students, of all academic backgrounds. Requirements Our Good Manufacturing Practice (GMP) 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 Learning this new skill will help you to advance in your career. It will diversify your job options and help you develop new techniques to keep up with the fast-changing world. This skillset will help you to- Open doors of opportunities Increase your adaptability Keep you relevant Boost confidence And much more! Course Curriculum 9 sections • 9 lectures • 05:38:00 total length •Basic Concept of GMP and Safety Regulations: 00:41:00 •Good and Bad Manufacturing Practice: 00:44:00 •Preventing and Controlling Contamination: 00:37:00 •Maintenance and Hygiene: 00:41:00 •GMP for Pharmaceutical Industry: 00:56:00 •GMP for Food Industry: 00:34:00 •GMP for Cosmetics Industry: 00:54:00 •IT Applications on GMP: 00:31:00 •Assignment - Good Manufacturing Practice (GMP): 00:00:00