Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

Why Should You Attend:

Investigations into unexpected results are usually time consuming and fraught with anxiety, as well as being subject to Regulatory inspection. Using a Root Cause Analysis approach can reduce the time necessary to complete the investigation and simultaneously help, by pointing to appropriate Corrective and Preventative Action (CAPA) reduce the probability that additional OOS results from the same cause will be observed.

This webinar will point out some of the goals of effective investigations, and how you can use Root Cause Analysis and Corrective and Preventive Actions to accomplish these goals.

Upon completion of this course the learner should be able to:

• 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 finding the true root cause and some techniques to assist in finding it.
• 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 in the Webinar:

• 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

Who Will Benefit:

The following personnel in pharmaceutical laboratories will benefit from this training:

• Chemists
• Supervisors and Managers (Innovator and Generic companies for Human and Animal products, Dietary Supplements and associated Contract organizations)
• Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment
• Quality Control and Research
• Analysts and other laboratory staff
• Regulatory Affairs

Gregory Martin
Founder and President, Complectors Consulting LLC

Gregory 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 pharma 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.

Follow us :