Standardized risk assessment tool for harmonized selection & definition of environmental monitoring

Historically, Environmental Monitoring (EM) programs were designed based on higher-risk aseptic processes or opinions vs. an objective risk-based approach. Therefore, applying traditional EM design principles to barrier/isolator systems can introduce more risk than benefit as well as increased costs and resources.

BioPhorum Fill Finish have created a clearly defined global risk-based assessment tool for establishing environmental monitoring Performance Qualification (PQ) locations and transitioning to a routine monitoring program.

In this webinar, subject matter experts from BioPhorum’s Environmental Monitoring workstream will take you through the tool for establishing environmental monitoring Performance Qualification (PQ) locations and transitioning to a routine monitoring program.

🗣️Our speakers:
- Frederic Ayers, Research Scientist, @EliLillyandCompany
- Manshi Patel, Associate Director for Microbial Control and Sterile Support, @MSDintheUK
- Dawn Watson, Director of Sterile & Validation Center of Excellence, @MSDintheUK

Chapters:
0:00 Webinar introduction and agenda
1:55 Introducing BioPhorum
4:08 Environmental monitoring risk assessment tool development
10:33 Process overview
14:44 Case study example
21:41 Conclusion
22:50 Q&A

#biopharma #toolkit #environmentalmonitoring #BioPhorum #fillfinish