Laboratory Investigation of Out-of-Specification Observations

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Learn what it takes to Conduct an Adequate OOS investigation with Jerry Lanese

FDA has reported inadequate investigation of laboratory out-of-specification (OOS) test results in a number of 483 and Warning Letter observations. OOS investigations are disruptive to the flow of work in the laboratory. The procedures are complex and it is easy to not follow the procedures.

Our expert Jerry Lanese arms you with expert strategies on how to conduct an adequate OOS investigation and provides some insights as to what should be in the OOS procedure in this power packed audio seminar.

Plus, this session will provide a flow diagram which supplements the diagram provided in the FDA guidance on OOS investigations. It will also include the history of the interest in OOS investigations to give the audience an appreciation of how extensively the FDA inspects laboratory OOS records.

Here are few additional topics covered in the session:

  • What is the OOS investigation process?
  • Phase 1 OOS investigation (The laboratory)
  • Phase 2 OOS investigation (The laboratory and beyond)
  • What should be in a retest protocol?
  • What should be reported to Quality Assurance?

Topics covered in the session:

  • Out of Specification Investigations
    • Requirements
    • Impact of the Barr decision
    • Terminology
    • Laboratory Investigations
    • Involvement of QA

Who should attend?

Laboratory Managers, Laboratory supervisors, Laboratory record reviewers, Laboratory analysts, Quality Assurance record reviewers, Quality Assurance managers

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About Our Speaker

Dr. Jerry Lanese - Pharma Guidelines Expert

Dr. John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...   More Info
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