Short Course Listings
Short Course

Course Information
Course Title: Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results
Categories: 1 - Pharmaceutical Sciences
2 - Quality/Regulatory/Compliance
Instructor(s): Greg Martin Course Number: 113
Affiliation: Complectors Consulting
Course Date: 03/04/2017 - Saturday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) 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, 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.

Target Audience
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

Course Outline
-The FDA Guidance for Industry on Investigating OOS Test Results
o Phase I Lab Investigation
o Phase II Full Scale Lab and Production Investigation
o Investigation Report
-Conducting the Investigation
o Creating an Investigation Checklist
o Root Cause Analysis
o Considering Other Batches
o Retesting
-Evaluating the Outcomes: Has the Root Cause been identified?
-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. 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. He can be contacted at