Tuesday February 20, 2018
12:00 Noon – 1:30 pm EST
Instructor: Marsha Steed (Hardiman)
The sterility test is a critical lot release component for the manufacturing of sterile products. When sterility test positives are observed, a thorough and formal investigation is required. The compendial sterility test methodologies are harmonized for the United States, Europe and Japan. This harmonized compendial method offers guidance on how to conduct sterility test investigations. In addition, the FDA’s guidance document for aseptic processing, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, provides guidance on conducting a sterility test failure investigation. This course will describe the actions that should be taken when a sterility test failure occurs. In this course we will discuss:
- Sterility Test Failure Investigation Regulations and Guidance
- Sterility Test Failure Actions to be Taken
- How to Conduct Thorough Sterility Test Failure Investigations
- Risk Analysis Tools for Root Cause Determination
- Lab Investigation and Manufacturing Area Investigation Steps
- Impact to Affected Production Lots
- Investigation Timeliness
- How to Best Document the Investigation
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-017