GAMP 5 2nd Edition - What is new? - Online Training Recording

GAMP 5 2nd Edition - What is new? - Online Training Recording

Costs

ECA-Member*: EUR 990,--
Regular Fee*: EUR 1190,--
EU/GMP Inspectorates*: EUR 595,--
APIC Member Discount*: EUR 1090,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

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

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?
  • 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
Recording from 2 November 2022
Duration of the recording: approx. 5 h 40 min

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