Keeping current with the latest regulatory requirements and industry guidance can be a challenge when you have a hundred and one tasks to complete.
The “What’s new in GAMP®5 2nd Edition (July 2022)?” 1 Day course goes through the fundamental differences between the first and second editions.
Identify the differences between GAMP®5 first edition and second edition (revised edition) and the reasons for the changes.
Content:
Identify the differences between GAMP®5 first edition and second edition (revised edition) and the reasons for the changes.
Why wasn’t this the GAMP 6 Guide?
The impact of technological innovation
An overview of the additions, retired material, and new appendices
Exploring Appendix M12 Critical Thinking
Introducing the new Appendix D8 Agile working
Considering how the guiding fundamentals of Agile working can be consistent with GAMP® 5 and GxP principles including areas such as:
The FDA’s Technology Modernization Action Plan
Waterfall methodology vs Agile methodology
Iterative and Incremental Approach to achieve compliance
Scrum Framework Model
Introducing Appendix D11 Artificial Intelligence and Machine Learning
Gain an overview of the new content, opportunities, and challenges
Latest guidance on how to manage risks related to Artificial Intelligence (AI) and Machine Learning (ML)
Exploring examples of where AI and ML are used in the healthcare industry
Exploring Appendix D9 Software Tools
Investigating Appendix D10 Distributed Ledger Systems (Blockchain)
Overview of the new Appendix M11 on IT Infrastructure including:
The Five Components of IT Infrastructure
Infrastructure Risk Management
IT Infrastructure Qualification Plan
Cloud Infrastructure