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Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

Thursday, 19 July 2018 11:30 AM PDT, 02:30 PM EDT

Training Duration = 90 min                  Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

This training on pharmaceutical laboratory OOS investigations will explain how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.

Learning Objectives:

Upon completion of this course the attendee should:

  • Be familiar with various terms associated with investigations of atypical or out of specification results, and how to document those investigations
  • Be familiar with the FDA Guidance for industry on investigating Out-of-Specification (OOS) test results for pharmaceutical production and how to apply it in laboratory situations
  • Be able to create a Laboratory Investigation Checklist and effectively document an investigation, including rationale and results
  • Know the importance of Corrective and Preventative Action (CAPA) and be able to identify appropriate CAPAs
  • Understand practical strategies to utilize outcomes from investigations for continuous improvement and reduction of future OOS results

Why Should You Attend:

Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely.

Specifically, there is a concern as to whether the laboratory and the company apply good science to the investigation of laboratory test results that are out-of-specification or outside of statistically expected ranges.

Areas Covered

  • What constitutes an atypical or out of specification result?
  • The Barr decision of 1993 and its impact on OOS investigations
  • The FDA Guidance for industry on investigating OOS test results
  • Reporting data
  • Conducting the investigation
  • Creating an investigation checklist
  • Considering other batches
  • Retesting
  • Evaluating the outcomes: Is there an assignable cause?
  • Documenting the investigation
  • Utilizing outcomes for continuous improvement
  • Questions and discussions


Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years.

In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.

Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.