Short Course Listings
Short Course

Course Information
Course Title: Conducting Effective Investigations of Atypical and Out of Specification Laboratory Results
Categories: 1 - Pharmaceutical Sciences
2 - Quality/Regulatory/Compliance
Instructor(s): Gregory Martin Course Number: 162
Affiliation: Complectors Consulting
Course Date: 03/18/2013 - Monday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $480 ($680 after 2/18/13) Textbook Fee:

Course Description
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, performing appropriate investigations Upon completion of this course the learner should: 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.

Target Audience
Chemists, Supervisors and Managers in Pharmaceutical Laboratories and Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment.

Course Outline
• Assessment of Attendees Backgrounds and Interests
• 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
o Creating an Investigation Checklist
o Considering Other Batches
o Retesting
• Evaluating the Outcomes: Is there an assignable cause?
• Documenting the Investigation
• Case Studies
• Interactive Workshop: Participants’ Examples
• Utilizing Outcomes for Continuous Improvement
• Questions and Discussions

Course Instructor's Biography
Greg 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. 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 and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group. He can be contacted at