GAMP 5 2nd Edition - What is new? - Online Training Recording
Course No. 20668A
Speakers
Yves Samson
Kereon
Dr Bob McDowall
R.D. McDowall Ltd.
Frank Behnisch
CSL Behring
Stefan Münch
Körber Pharma Consulting
Dr Robert Stephenson
Rob Stephenson Consultancy
Objectives
Get to know the differences between GAMP®5 and GAMP®5 2nd Edition.
What are the changes in the main part?
What are the changes in the management and Operation appendices?
How has the 2nd edition been affected by new technological developments
Critical Thinking in and about the 2nd Edition
FDA CSA (Computer Software Assurance) and the 2nd Edition - how do the two fit together?
Background
With GAMP®5, published in 2008, this guide became the globally accepted standard for the validation of computerized systems. Due to new technological (Artificial Intelligence / Cloud Computing / Agile Software Development) and regulatory developments (ICH Q9 / FDA initiative in CSA), there was a need for adaptations after 14 years. These adaptations have now been integrated into the 2nd Edition, which has been available since July 2022.
The publication of a 2nd Edition instead of a completely new GAMP®6 shows that the basic principles of GAMP®5 are still relevant. In the 2nd Edition, changes and further developments have been made according to the motto evolution instead of revolution.
Target Group
This Online Training is directed at employees from
Production
Quality Control / Quality Assurance
Engineering
IT
who have to deal with GAMP®5 in the field of computer validation.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
GAMP®5 Second Edition - What’s Different - What’s New?
Reasons for a Second Edition
Critical Thinking
Advancing Technology
Enabling Innovation
Changes from the original GAMP®5 – a section by section overview
What has been retained?
Significant revisions
New Topics
How will this affect current good CSV practice?
Key Messages
Expected improvements
IT Infrastructure / Cloud Computing
Summarising Appendix M11
IT Infrastructure changes in the 2nd editio
General impact on CSV and GAMP®5 best practices
Agile Software Development
Software Tools
Summary of new Appendix D9
Enabling innovation, increasing quality
Compliant selection and handling of tools for CSV
Critical Thinking
What the industry oversaw (ignored?) during the last 20 years
Enabling Innovation and GAMP®5 2nd Edition
Quality Risk Management: the keystone process for Critical Thinking
Practical application of critical thinking in projects and processes
GAMP®5 2nd Edition Impact on System Suppliers
Differences between GAMP®5 1st and 2nd Edition
Could system and equipment suppliers leverage critical thinking and CSA?
Testimonials