Sterility testing is widely used in both the medical device and pharmaceutical industries. The pharmacopeia test is the official procedure for testing the sterility of pharmaceutical products. Despite its importance and its widespread use, many people are not aware of the limitations of the sterility test and are unsure how to proceed when a failure investigation occurs.
01/25/2018 10:00 AMTraining Topic: Investigating Sterility Test FailuresInstructor: Tim Sandle
Questions to help with this process, like -- "Can the test be invalidated? Is the product rejected? What needs to be investigated? How is root cause established? What need to be done before production can resume?"-- will be answered in this webinar.
Objectives of the Presentation
What the sterility test can and cannot demonstrate
The causes of sterility test failures
The actions required on being notified of a failure, including deviation management and quarantine
Best practices for laboratory test investigations
Best practices for processing investigations
Best practices for aseptic processing investigations
Developing a remediation plan including the necessity for media simulation trials
Why Should you Attend
To gain an insight into the best practices for sterility test failure investigations, from a speaker who has presented sterility test failure investigation reports to both FDA and European Medicines Agency inspectors.
History of the sterility test
Statistical limitations of the sterility test
Actions required by management on being notified of a sterility test failure
The importance of genotypic microbial investigation
Points to consider for investigating testing, such as cleanroom or isolator operational parameters
Reviewing major contamination incidences in process areas that could lead to a sterility failure, from raw materials to wet equipment
Detailed forensics for aseptic process investigations, such as reviewing people, processes and equipment