Specification Test 2020 - Dealing with Out of Specification Test Results in FDA Regulated Industries

What to do and what not to do when it comes to testing and retesting FDA regulated products in the medical device, pharmaceutical and food industries is what this webinar is about. When an out of specification (OOS)
Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production Additional copies are available from: Office of Training and Communication Division of Drug Information HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600
Will review FDA expectations based on their Guidance document for OOS
Will incorporate several OOS examples based on the FDA Guidance Document for dealing with OOS Test results so you can integrate them into your company SOPs
Will discuss pathways for successfully interpreting regulatory expectations for retesting
Speaker:
Meena Chettiar, has worked as a Scientist for Health Canada and as a Quality Management Professional in food, pharmaceutical and medical device industries for over 25 Years in Canada and the United States.