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Faculty: HitendraKumar Shah ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3520

  • Date: 11/8/2022 10:00 AM - 11/8/2022 12:00 PM
  • Time zone: Eastern Time (US/Canada) Online Event


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.