E16-27: Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

Using Root Cause Analysis and CAPA to Close Them Quickly and Keep Them from Coming Back

One-Day Course
Tuesday, November 15, 8:30am-5:00pm

Mr. Gregory Martin, Complectors Consulting, Pottstown, PA

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.

 Upon completion of the course the learner should be able to:
1) Be familiar with various terms associated with investigations of atypical or out of specification results, and how to document those investigations.
2) 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.
3) Be able to create a Laboratory Investigation Checklist and effectively document an investigation, including rationale and results. 
4) Know the importance of Corrective and Preventative Action (CAPA) and be able to identify appropriate CAPAs.
5) Understand practical strategies to utilize outcomes from investigations for continuous improvement and reduction of future OOS results.

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.

1. The FDA Guidance for Industry on Investigating OOS Test Results
     * Phase I Lab Investigation
     * Phase II Full Scale Lab and Production Investigation
     * Investigation Report
2. Conducting the Investigation 
     * Creating an Investigation Checklist
     * Root Cause Analysis
     * Considering Other Batches
     * Retesting
3. Evaluating the Outcomes:  Has the Root Cause been identified?
4. Documenting the Investigation
5. Case Studies
6. Interactive Workshop:  Participants’ Examples
8. Utilizing Outcomes for Continuous Improvement
9. Questions and Discussions

Mr. Greg Martin is 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 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 as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances, 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.  He is also Past Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.  Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.