The first part of the Symposium is devoted to the requirements, development and validation of sterilisation methods and related Biological Indicators (BIs). Participants will learn about the revised Ph. Eur. 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).
Focus is given to:
- the main changes in these revised chapters and their impact on microbiological control;
- the implementation of sterilisation processes for medicinal products: validation and practical issues;
- role of biological indicators in sterilisation validation.
The second part covers Rapid Microbiology Methods. Participants will learn about:
- the new structure and content of the revised Ph. Eur. chapter Alternative methods for control of microbiological quality (5.1.6);
- the regulatory framework;
- validation of Rapid Microbiology Methods (RMMs) and the role of statistics, with specific sessions on validation of RMMs for the control of cell therapeutic products and microbiological control of pharmaceutical water;
- new trends and perspectives.
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Target audience
This Symposium is of interest to staff members of national regulatory bodies and scientists involved in the development, manufacturing, quality control, quality assurance and licensing of medicinal products.
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- EU Regulations for Medicines by Cathie Vielle
- Day 1, Morning Session : Sterilisation and biological indicators
- Day 1, Afternoon Session: Rapid Microbiological Methods: Regulatory Perspectives 1
- Day 1, Afternoon Session: Rapid Microbiological Methods: Regulatory Perspectives 2
- Day 2, Morning Session: Rapid Microbiological Methods: examples of Success Stories
- Day 2, Afternoon Session: Microbiological Control of Cell Therapy Products
- Day 2, Afternoon Session : Microbiological Quality of Water
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