OOS Test Results – Latest FDA Guidance

🎤 HitendraKumar Shah | 📅 November 8, 2022 | 🕒 10 AM Eastern Time US

Description:

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. 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 :

Defining an Out of Specification Result
Latest FDA Guidance for dealing with OOS, its intention and its applicability
Responsibilities of personnel involved
When and at which stage can you confirm the OOS test result
When a full investigation should be triggered
Root Cause Analysis Methods
Handling various OOS scenarios
Frequency for re-testing and re-sampling
Do’s and don’ts of retesting as per latest guidance
Implementing a proper CAPA plan

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.