Click the gear icon for captions in other languages.
Have questions for our experts or want more information?
Contact Us Today
Webinar Overview
Upgrading equipment or modifying workflows in the quality control (QC) lab can feel overwhelming, especially for microbiologists who may be unsure of where to begin or how to ensure compliance from the start. Without proper planning, even well-intentioned improvements can lead to unexpected regulatory gaps and costly rework.
This webinar offers a practical approach to navigating lab upgrades with confidence. Gain insight on pre-implementation considerations from a former FDA unit supervisor and analyze a case study of a laboratory that changed its final sterility release test. Designed as a “prep-before-you-step” guide, industry experts will share critical knowledge that will empower you to make informed, compliant, and efficient lab improvements.
Key takeaways include:
- How to approach regulatory agencies for planned changes in your QC micro lab
- Actionable insights for Celsis® rapid method adoption in your own lab via analysis of a Baxter Round Lake case study
- Regulatory expectations for implementing rapid microbiological methods in alignment with USP <73>
Webinar Presenters
Erika Pfeiler, PhD
Senior Consultant
Valsource
Joseph Wolinski, MS
Senior Technical Consultant
Baxter International
Scientific Moderator
Jonathan Kallay, BS, PGDip
Senior Scientific Portfolio Specialist
Charles River
Additional Information
- Accelerating Contamination Detection in Short-Life Products with Celsis®
- Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation, and Global Implementation
- Implementing Rapid Sterility Test Systems: A Guide from the Experts
- The Evolution of Eco-Conscious Endotoxin Testing