The new Annex 1: Have you already implemented it? Four-part training (10658)

At the end of August, the requirements of the complete revised Annex 1 must be implemented under EU GMP. Our webinars provide a comprehensive overview of the most important requirements. Furthermore, there are practical tips explained and suggestions for the implementation of the "contamination control strategy", probably the most significant change in the new version. In the last part of the webinar, many examples for the preparation of the CCS will also be presented. Fritz Röder has been involved in the development of Annex 1 for years and has expertise in sterile manufacturing and the evaluation of GMP aspects.

What does Fritz Röder offer in his webinar?

• Incorporating inspector responses to Annex 1 and implementation concepts.
• Practical implementation of the inspection strategy and GAP analysis, with information on all individual chapters
• Experiences from the implementation of Annex 1 - what works, what does not work?
• Significantly more information and explanations of many details, assistance in interpreting complicated passages
• Revision of the topics "Barrier Systems" and "Handling of Gloves

Content of the four-part webinar:

Part 1
Duration: ca. 90 Minutes

• Introduction
• QRM / control strategy
• Buildings ("Premises")
• Ventilation
• Production layouts

Part 2
Duration: ca. 90 Minutes

• Barrier systems
• Equipment
• Cleaning validation / biodecontamination
• Water and steam
• Compressed air and product-wetted gases

Part 3
Duration: ca. 90 Minutes

• Production
• Optional control
• Sterilisation, disinfection
• Aseptic handling
• Filtration & PUPSIT, Single-Use Systems

Part 4
Duration: ca. 90 Minutes

• Monitoring and QC / Exit Monitoring
• Aseptic Process Simulation
• Practical implementation of the control strategy (examples)
• Practical tips
• Proposal for structuring of the CCS

Duration in total approx. 6 hours

Presentation Language: English | Slides: English

...more about your speaker Fritz Röder...

Webinars allow you to conveniently attend training sessions and technical presentations from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.

Note on quota call-off: When booking this webinar-series described here, four units will be deducted per participant.

For whole teams we offer attractive special prices with special advantages or develop your own in-house training for you - please contact us.