Troubleshooting Microbial Excursions Best Practices - FDA and USP Regulatory Expectations
: 26 Jun 2019
Sector: Clinical, Pharmaceutical
Type: Training, Webinar, Seminar
Microbial Excursions are an often observed issue that occur with both non-sterile and sterile products in controlled and classified environments as well as within the microbiological laboratory. This live training webinar will review various investigations – using various FDA warning letters to explore issues with bacteria and fungi. A chronology will also be included that reviews “Troubleshooting Microbial Excursions”.
- An Overview of “Best Practices for Troubleshooting Microbial Excursions”.
- Various Code of Federal Register regulations, USP and FDA Guidance for Industry documents used by Regulators in Citations.
- Learn about the Legal Framework behind these Documents.
- Learn about Laboratory, the Classified Environment, Non-conformances of Personnel, and Cleaning and Disinfection Practices.
- Participate in an Overview of a “Troubleshooting” Exercise.
- Experience what Companies have encountered with Warning Letters.