This presentation will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle. The concepts will be discussed in the context of a product lifecycle including examples of how they might be applied.
Topics specifically addressed will be:
- Product and packaging
- Manufacturing process design
- Evaluation and selection of materials
- Microbiological process controls and testing
- Sterility assurance validation and maintenance
- Change control
This webinar is part of our 2-day live, pharma webinar series “Pharmaceutical Sterility Assurance, Contamination Control, and Extractables & Leachables” which will be held on 30 September and 1 October 2020. These webinars, presented by Expert Advisors from Sterigenics, Nelson Labs and Noxilizer are designed to bring you insights into the latest developments and innovations in Pharma Sterilization (Sterilization technologies & sterility assurance), Extractables & Leachables testing (Instruments & techniques & regulatory requirements), as well as Bacterial Endotoxin testing.
Webinars in this series include:
- Gamma Radiation & EO/NO2 Sterilization: Concepts & Pharma Applications
- Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems
- Bacterial Endotoxin Testing; History, Inhibition/Enhancement, & Process Control
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