This webinar will give you an introduction to the most important new requirements expected in the new Annex 1. With only 6 months of expected implementation time you will need to be on top of the many new requirements already now.
The Annex 1 “Manufacture of Sterile Medicinal Products” of the EU GMP Guideline is currently being updated with the latest improvements in manufacturing science. The first draft as published in 2017 which received more that 6.000 comments and now the second draft has been released with their comments. Final version will follow immediately after this second draft version.
Once finalized, Annex 1 will have a significant global regulatory impact, not only on products regulated by the European Union, but since the same document is being review by PIC/S which includes FDA as well as WHO those regulated by these authorities are likely to adopt the recommendations of this document into their own regulatory requirements.
Remember that the FDA guidance to industry on “Sterile Drug Products Produced by Aseptic Processing” is from 2004 which is also in for an up-date. This webinar will update you on the current EU draft and give an overview of the modifications that have been implemented compared to the current 2011 version.
|10:00 AM||Log In Period|
|10:20 AM||History and Regulatory Impact of Annex 1,|
|Contamination control strategy, Pharmaceutical, Quality System, and
|Cleanrooms and environmental monitoring,|
|Aseptic Processing Simulation|
|11:45 AM||Sterile Filtration|
|Use of enhanced barrier technology,|
|Personnel Qualification and Behavior,|
|Summary and conclusions|
|13:00 PM||Live Questions & Discussion|
The following individuals or disciplines will benefit from attending this Webinar:
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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