GAMP 5 2nd Edition - What is new? - Live Online Training
Wednesday, 2 November 2022 9 .00 - 18.00 h
Course No. 20668
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
Note: All times mentioned are CET.
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 Live 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 Requirements
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.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials
Seminar Programme as PDF