Recording Webinar: Annex 1 - Container Closure Integrity Testing

Recording Webinar: Annex 1 - Container Closure Integrity Testing

Costs

ECA-Member: EUR 199,--
Non ECA Member: EUR 249,--

(All prices excl. VAT)

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

Speakers

Matthias Schaar, Technical Steward Microbiology, Novartis Pharma

Background

Container Closure Integrity in pharmaceutical sterile production is a requirement to maintain sterility of the drug product. After the USP chapter 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.

Target Group

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

Programme

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.
 
 
Duration of the Recording: Appr.1,5 h

Recording from 28 August 2020

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