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Conducting Effective Investigations of Out of Specification and a typical Laboratory Results

Summary

  • What Constitutes An Atypical or Out of Specification Result?

  • The FDA Guidance for Industry on Investigating OOS Test Results

  • Phase I: Initial Laboratory Investigation

  • Phase II: Full-Scale Investigation

  • Tools for finding the Root Cause

  • Testing the hypotheses regarding potential root causes

  • Retesting

  • Considering Other Batches

  • Corrective and Preventive Action (CAPA)

  • Documenting the Investigation

  • Case Study

  • Questions and discussion

Overview

This course is designed to provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, and how to perform investigations to assure both compliance and good business decisions.  The course stresses timely, consistent investigations focused on identifying the root cause and taking appropriate actions regarding the disposition of the data and the material, as well as corrective or preventive actions to avoid similar situations in the future.  There will be an exercise using a participant’s example to work through an investigation, as well as ample opportunity for questions and discussion.

Who should attend?

Chemists, Supervisors, and Managers in Pharmaceutical (Human or Veterinary), Generic, OTC or Contract Laboratories and Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment.

Gregory Martin

Expert

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

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