Recording Webinar Annex 1 - Quality Risk Management using the example of the Contamiation Control Strategy
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
Dr Franz Schönfeld, GMDP inspector for EMA and local authorities, Germany
Background
Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment, which resulted in thousands of comments. A revised second version was published in February 2020 and is open for limited comment by selected stakeholders.
Target Group
This webinar is addressed to employees of pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibility in
- Quality assurance and quality control
- Inspections and audits
or who are active in
- Sterile/aseptic production
- Contamination control and monitoring
- Process Simulation/Media Fill
Programme
This webinar teaches the basics of quality risk management and its practical application using the example of contamination control (CCS Contamination Control Strategy) according to the current draft for the revision of Annex 1 of the EU GMP guidelines. It explains the importance and the networking of risk-minimizing measures in the areas of personnel, design and processes within the overall concept of avoiding microbial contamination for the efficient planning and production of sterile dosage forms. Accordingly, this webinar covers the core requirements for
- Quality Risk Management
- Contamination Control Strategy
- Personnel
- Design
- Process flows
Duration of Recording: Appr. 1,5 h
Recording from 23 July 2020