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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”. 

 

Learning Benefits:

  • 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. 

Find out more / register here:

Venue


Organizer

PHARMA WEBINARS
Phone: +1 (877) 792.7587
Email: support@pharmawebinars.com
Visit: http://www.pharmawebinars.com


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FDA New Endotoxin Te...
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