OOS Test Results – Latest FDA Guidance

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.


HitendraKumar Shah

HitendraKumar Shah is a renowned Quality oriented professional with over 20 years of experience in Quality Assurance and Quality Control. During this period, he has been actively involved in process control, Finished product release, Investigations, product recalls and other quality notifications. He has helped numerous companies in ensuring CAPA implementation & effectiveness, Quality system review and reporting, Supplier audit, GMP training, risk assessment and validation activities. His Key Competencies are but not limited to Quality Compliance, Vendor Audit, data integrity, Risk assessment, Qualification & validation, Review and finalization of technical agreements. He is a popular figure on social media for his effective and easily understandable training bites.

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  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance