Frank Behnisch, CSL Behring, Germany Bob McDowall, R.D.McDowall, UK Stefan Münch, Körber Pharma Consulting, Germany Yves Samson, Kereon, Switzerland Dr Robert Stephenson, Rob Stephenson Consultancy, UK
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?
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.
This Live Online Training is directed at employees from
Quality Control / Quality Assurance
who have to deal with GAMP®5 in the field of computer validation.
We use Webex Events for our live online training courses and webinars.
At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
GAMP®5 Second Edition - What’s Different - What’s New?
Reasons for a Second Edition
Changes from the original GAMP®5 – a section by section overview
What has been retained?
How will this affect current good CSV practice?
IT Infrastructure / Cloud Computing
Summarising Appendix M11
IT Infrastructure changes in the 2nd editio
General impact on CSV and GAMP®5 best practices
Summary of new Appendix D9
Enabling innovation, increasing quality
Compliant selection and handling of tools for CSV
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?