Discussion of the applications related to Bioburden and Sterility Testing of IVD products has increased in the past few years. Microbiological contamination can affect safety, effectiveness, and time to get product to market. In this webinar, you will learn about applicable regulations, an overview of methods, development of a risk-based sampling plan, and the available services to guide you through selecting the best test for your needs.
Topics to be covered include:
- BioBurden and Sterility Testing Methods
- Regulatory Guidelines
- Selecting the Proper Testing Solution
This in-depth webinar will be valuable for all of those involved in bringing diagnostic assays to market including:
- IVD Assay R&D Scientists
- IVD Research Scientists
- IVD Manufacturing Scientists
- QA/QC Personnel
Speaker
Anne Connors
Merck
Senior Field Marketing Manager
Anne Connors is a Senior Field Marketing Manager at Merck, specializing in pharmaceutical microbiology applications. Anne’s areas of expertise are in Environmental Monitoring, Pyrogen, and Sterility testing, as well as pharmaceutical microbiology regulations. Anne holds a B.S. in Organismal Biology and has over 14 years of industry experience. Previous to her role at Merck, she was a Senior Scientist in QC Microbiology, specializing in validation and method development and as a subject matter expert. Anne is also actively engaged as volunteer faculty and for the PDA.
Clinical testing and diagnostics manufacturing
- Microbiological testing
Duration:1h
Language:English
Session 1:presented June 16, 2021
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