Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes 2019 is a webinar that covers topics such as:
- 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
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes 2019 is intended for 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