Conducting Effective Investigation of Out-of-Specs and Atypical Laboratory Data

Course Description:

Deficiencies of OOS investigations continue to be the major cause of warning letters in the pharmaceutical industry. The FDA requires that all out-of-specification results must be investigated; therefore, an effective and compliant quality management system requires well-documented, thorough investigations for OOS. Key challenges for many companies are having a clear understanding of regulatory expectations on how to handle OOS and OOT (Out Of Specification and Out Of Trend). Lack of consistency around investigation and root-cause analysis processes will lead to error and expensive laboratory activities.

Learning Objectives:

• Understand regulatory expectations for OOS (Out Of Spec) investigation
• Define documentation system for reporting data
• Build ruggedness into the analytical procedures to prevent OOS occurrences
• Build compliance into the investigation process to minimize OOS
• Define and monitor Corrective and Preventive Actions

Kim Huynh-Ba
Executive Director of Pharmalytik

Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Ms. Huynh-Ba currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. She has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.