Sunday, 21 January 2018

Webinar - Investigating Sterility Test Failures

New webinar - January 25, 2018

Date: Thursday, 25 January 2018 | Time: 10:00 AM PST, 01:00 PM EST | Duration: 60 Minutes

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.


Instructor: Tim Sandle
Product ID: 503878

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 trialsWhy 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.

Areas Covered

  • 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
  • How to do put an investigation report together
  • How to test out CAPA through media fills
  • What to do if the investigation is inconclusive
For details, see Online Compliance Panel.

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