Yves Samson
Kereon
Referent:innen
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.
Zielsetzung
- 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?
Hintergrund
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.
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.
Zielgruppe
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.
Programm
Gesamtes Programm als PDF herunterladen
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
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?
- Persistent expectations
- Supplier maturity: facilitating Leveraging Supplier Involvement
Artificial Intelligence and Machine Learning (AI / ML)
- Summary new appendix D11 & Life Cycle Approach
- Concept Phase
- Project Phase & supporting processes
Pros / Cons
- Individual statements from the speakers
- Panel discussion
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