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

• The role of critical thinking in risk management

• Addressing the interplay of multiple systems and the data life-cycle

• Addressing human factors

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

• Develop an understanding of the new guidance for software tools

• Gain an overview of the key issues and challenges

Investigating Appendix D10 Distributed Ledger Systems (Blockchain)

• Gain a high-level understanding of distributed ledger system

• Approach to Controls and Cryptographic Agility

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