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.
Learning Objectives:
- Be familiar with various terms used by regulators 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.
Areas Covered:
- Review of recent FDA Warning Letters regarding OOS results
- Gauging the impact of OOS results
- Get familiar with The FDA Guidance for Industry on Investigating OOS Test Results and the terminology inspectors will use
- Initiating an Investigation
- EXERCISE: Assess several examples to evaluate how much work is necessary
- Conducting the Investigation
- Documenting the Investigation
- Evaluating the Outcomes: Were you effective in identifying the real problem (root cause)?
- EXERCISE: Discuss your challenging investigations and get feedback from the instructor and attendees
- CAPA
- Questions and Discussions
Who will benefit:
- Supervisors and Managers in Pharmaceutical (Human or Veterinary)
- Chemists
- Generic, OTC or Contract Laboratories
- Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment
- 8:30 AM - 8:59 AM: Registration Meet & Greet.
- 9:00 -10:30
- Seminar objectives review, expectations and scope.
- Review of recent FDA Warning Letters regarding OOS results
- Gauging the impact of OOS Results
- Get familiar with the FDA Guidance for Industry on Investigating OOS Test Results
- 10:30-10:45 Break
- 10:45-12:00
- Initiating the Investigation: Types of issues (OOS, Atypical, Stability, etc.)
- When do you need to initiate and investigation?
- When can you wrap up an investigation quickly?
- WORKSHOP: Assess several examples to evaluate how much work is necessary
- 12:00-1:00 Lunch
- 1:00-2:30
- Conducting the Investigation: Creating a Checklist, Root Cause Analysis, Retesting, Considering Other Batches
- Documenting the Investigation
- Evaluating the Outcomes: Were you effective in identifying the real problem (root cause)?
- 2:30-2:45 Break
- 2:45-4:30
- WORKSHOP: Discuss your challenging investigations, and get feedback from instructor and attendees
- CAPA (Corrective and Preventive Action)
- Utilizing Outcomes for Continuous Improvement
- Additional Questions and Discussion
Gregory P. Martin
President of Complectors Consulting LLC
Greg Martin is President of Complectors Consulting (www.complectors.com) 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 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 author of several papers in the areas of dissolution and analytical method validation, and is past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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