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CPHI Webinar Series
Product Safety: Future State of Sterility Assurance and the Role of Terminal Sterilization
What will this webinar address?
Sterilization is a pivotal step in the pharmaceutical drug development process to help ensure overall safety is maintained. Regulation is clear that, whenever possible, products intended to be sterile should be terminally sterilized in their final container. Only if terminal sterilization is not possible, filtration or aseptic assembly should be applied. This webinar will focus on trends in the concept of sterility assurance including the revision of USP <71> and elements to evaluate prior to selecting aseptic assembly for the manufacturing of sterile drug products.
What will you get from this webinar?
- A deeper understanding of terminal sterilization and aseptic processing of drug products through a regulatory lens as well as that of a manufacturer.
- Trends in the concept of sterility assurance.
- Mitigation strategies for the use of terminal sterilization with radiation, ethylene oxide and novel modalities.
Annick has accumulated 15 years of experience in ethylene oxide sterilization field, quality management and pharma manufacturing. In her role as Technical Director, EO Pharma, Annick leads the Ethylene Oxide (EO) sterilization projects at numerous Sterigenics facilities and supports the facilities as the technical expert with pharmaceutical project responsibility. She’s now also supporting the development and validation of nitrogen dioxide projects in Sterigenics European facilities.
A seasoned speaker, Annick presents at industry conferences—such as CPHI and the A3P Congress. Annick has also been published in Medical Design & Outsourcing. Annick often presents on innovative and customized solutions for terminal sterilization of pharmaceuticals.
Education: Biochemistry Graduate of Haute Ecole Liège (Belgium), DES Total Quality from Faculté Polytechnique (Belgium), Management of Pharmaceutical Quality Systems from the ECA Academy.
Certifications: Certified Trainer, EO Sterilization Validation
Expertise: EO Sterilization Validation of Medical Devices and Pharma Applications (API, drug products, combination products), Cycle Design and Development, Process Definition and Performance Qualification Studies, PCD Development, D-Value Determination, EO Residues, Nitrogen Dioxide Sterilization.
This webinar is brought to you by
December 2nd, 2021
4pm CET / 11am EST
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