Handling OOS Test Results as per Latest FDA Guidance – 2022

Out of Specification (OOS) Test Results presents a major challenge to several in house and contract testing laboratories as FDA and other regulatory agencies’ expectations in this area are very rigid and specific. Successfully interpreting regulatory expectations in this area and practically dealing with OOS results for pharmaceutical, cosmetic, Vitamins, minerals and supplements and medical device industry based on USP, non USP chemical, microbiological and physical test measurements will be described in this presentation.

Based on Meena Chettiar’s vast experience in dealing with OOS results in pharma, food and medical device testing and questions raised on OOS in several FDA and regulatory audits, many practical examples will be presented from which you can lay a strong foundation for Successfully Dealing with Out of Specification (OOS) Test results in FDA Regulated Industries per the latest Guidance document.

The speaker will incorporate several examples based on the FDA Guidance Document for dealing with OOS Test results so you can integrate them into your company SOPs and ensure that your OOS investigations are able to withstand the strong audit scrutiny when you are questioned at FDA and other key audits of your OOS test results.

You should attend this presentation to dissect and deal your OOS test results successfully, and document it perfectly in your quality system and avoid unnecessary 483’s in this area.

Areas Covered in the Session :

The speaker has first hand experience dealing with FDA on OOS test results in food, pharma and medical device industries for over 25 years and hence will share her experience with several examples during this webinar.

• FDA Guidance document for dealing with OOS, its intention and its applicability
• When and at which stage can you confirm the OOS test result?
• Root Cause analysis aids at different phases of the investigation
• Various challenging OOS scenarios and how can one deal with them successfully
• Core responsibilities of Personnel involved in testing, releasing and receiving FDA regulated products
• Acceptable path forward on encountering aberrant OOS test results
• FDA Guidance document on dealing with out of specification/failing test results
• Understanding do’s and don’ts of retesting as per latest guidance
• Criticality for product release
• What is allowed and what is not
• Areas to be looked at for a thorough investigation

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Quality Control Inspectors
• Quality Control Lab Technicians
• Scientists working in Testing labs in food, pharma and medical device industries
• Compliance auditors in FDA regulated industries
• Everyone working in FDA regulated industries involved in testing, releasing products and accepting products at all levels.