Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes 2019

  • 20 Feb 2019
  • Webinar

Description

Topics
  • Step by step process in conducting sterility test failure investigation and what to look for during the entire investigation process
  • Discuss the regulations guiding manufactured product sterility testing such as USP [71] Sterility Testing and how to ensure adherence to program testing requirements
  • Performing a product retest during a sterility failure investigation and how to apply corrective and preventative action based on the findings of a sterility failure investigation
  • Discuss the role of contaminant as a key tool during investigational process such as microbial identification of contaminant and if it is important or not important - why or why not?
  • Impact of sterility failure investigation for commercially distributed products under a stability testing program
  • How to disposition impacted products based on investigational findings while avoiding common mistakes during product disposition
Who should Attend

Attendees from:

  • Sterility Assurance
  • Quality Control
  • Senior Management
  • Manufacturing/Production
  • Supplier Quality
  • Raw Materials Tester
  • Quality Assurance
  • Regulatory Affairs
  • Design Engineers
  • Compliance
  • Contract Manufacturing Organizations (CMO)
  • Facility, Maintenance and Engineering
  • Chemical Suppliers
  • Active Pharmaceutical Ingredients Suppliers
  • Excipient Suppliers

Past Events

Important

Please, check "Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Pharma
Technology: Biotechnology

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