Matthias Schaar, Technical Steward Microbiology, Novartis Pharma
Container Closure Integrity in pharmaceutical sterile production is a requirement to maintain sterility of the drug product. After the USP chapter <1207> had a major update in 2017 with regard to testing methods and testing recommendations the new Draft of Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide also implemented a more detailed discussion about Container Closure integrity testing. The first revised version published in 2017 resulted in discussions about testing strategies which leaded to a new revised version published in February 2020.
This Webinar is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in
- - Quality Assurance and Quality Control
- - Inspection and Auditing
or who are involved in
- - Sterile/Aseptic Manufacturing
- - Contamination Control and Monitoring
- - Process Simulation/Media Fill
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.
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.
This webinar will give you a short overview about Container Closure requirements and method discussions and focuses the planned implementations in Annex 1 considering both drafts with regard to Container Closure Integrity Test.
Recording from 20 August 2020
Duration of the Recording: Appr.1,5 h