The EDQM will hold an international symposium on 10-11 October 2017 in Strasbourg (France) to present and discuss recent achievements, as well as future perspectives, of the Ph. Eur. in the microbiology field.
The symposium will cover the recent developments and the future changes of the European Pharmacopoeia (Ph. Eur.) in the microbiology field.
The first part will be devoted to the requirements, development and validation of the sterilisation Methods and the related Biological Indicators (BIs). Participants will learn about:
- The revised chapters entitled Methods of preparation of sterile products (5.1.1) and Biological indicators and related microbial preparations used in the manufacture of sterile products (5.1.2): Highlight on the principal changes described in these revised chapters and their impact on microbiological control.
- Implementation of a sterilisation process for medicinal products: validation and practical issues role of biological indicators in sterilisation validation
- The second part will cover the rapid microbiology methods. Participants will learn about: the new structure and content of the revised chapter entitled Alternative methods for control of microbiological quality (5.1.6)
- The regulatory framework
- Rapid microbiology methods validation and the role of statistics
Specific sessions on:
- rapid microbiology methods for the control of cell therapeutic products
- microbiological control of pharmaceutical water
- new trends and perspectives
During both days, participants will have the opportunity to listen to those presentations and meet with the specialists who have been involved in the elaboration of the chapters.
At the end of the first day, you are cordially invited to a social event on the premises. This will be a great opportunity to share your experiences with other participants.
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Posted by Dr. Tim Sandle