Course Information
Course Title: Conducting Effective Out-of-Specs/Out-of-Trend Investigations
Categories: 1 - Liquid Chromatography
2 - Pharmaceutical Sciences
3 - Data Analysis
4 - Data Management
5 - Quality/Regulatory/Compliance
6 - Validation
Instructor(s): Kim Huynh-Ba Course Number: 116
Affiliation: US Pharmacopeia
Course Date: 03/15/2012 - Thursday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $455 ($655 after 2/13/12) Textbook Fee: $157 (Same text for Course 114)

Course Description
Deficiencies of OOS investigations continue to be the major cause of warning letters in the pharmaceutical industry. 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. Lack of consistency around investigation and root-cause analysis processes will lead to error and expensive laboratory activities. This session will discuss the Guidance for Industry on OOS/OOT investigation issued in October 2006 by the FDA. As testing become critical to determine the cause of OOS results, investigation process will be discussed and procedure that will minimize OOS and identify OOT. It will also discuss the documentation system as well as CAPA activities.

Target Audience
This course will benefit analytical chemists or investigator in QA/QC, R&D, project management, manufacturing, CROs, technical liaison, who are involved in the oos/oot investigations of pharmaceutical products. You must have at least 2 years experience in pharmaceutical industry to get the full benefit of this course.

Course Outline
I -  Understanding Regulatory Expectations on OOS/OOT
•Determine regulatory impact of OOS
•Review of warning letters relating to OOS/OOT
•Definition of OOS and OOT
•Outline a general OOS procedure

II - OOS Investigation Process
•Identifying and assessing OOS test results
•Phase I:  Laboratory Investigation
•Phase II:  Full Scale OOS Investigation
•Conclusions and Documentations

III - Understanding OOT and Documentation
•Recognize different types of OOT results
•Determine course of actions to process
•Understand cross-functional investigation
•Establish documentation and performance metrics

Course Instructor's Biography
Kim Huynh-Ba joined USP in early 2011 as Director of Pharmacopeial Education Department with almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Prior to USP, she was the Technical Director of Pharmalytik, where she advised pharmaceutical companies including companies operating under Consent Decree on harmonization and optimization of analytical best practices since 2003. Kim 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 teaching pharmaceutical analyses and analytical chemistry. Kim was a member of USP General Chapter Expert Committee (2010-2015), USP Reference Standard Project Team (2008-2010), and USP Prescription/Non-Prescription Stakeholder Forum. She is also a member of the CHPA’s Stability and Impurities Breakout Groups. She is on the steering committees of AAPS Trace Impurities, Stability, Contract Research Organization and CMC Focus Groups. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and will be their 2013 President. Kim has authored numerous technical publications and book chapters and has spoken extensively, both domestic and globally, in the areas of compliance and quality topics. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010).