Conducting Effective Investigation of Out-of-Specs and Atypical Laboratory Data
Kim Huynh-Ba, Executive Director of Pharmalytik
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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.
This one and a half day interactive seminar will discuss the Guidance for Industry on OOS/OOT investigation issued in October 2006 by the FDA. As testing becomes critical to determine the cause of OOS results, investigation process will be discussed during the session and it will also cover procedures that will minimize OOS and identify OOT. It will also make attendees familiar with the documentation system as well as Corrective and Preventive Actions (CAPA) activities.
- 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
Who will Benefit:
This session will benefit analyst to group manager who are responsible for acquiring, evaluating or reporting analytical results. It is designed to provide key principles for OOS and OOT investigations.
|Day One (8:30 AM - 4:30 PM)
||Day Two (8:30 AM - 12.00 PM)
8:30 AM - 9:00 AM: Registration Process
9:00 AM: Session Start
9:00 AM - 12:30 PM: 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
12:30 PM - 1:30 PM: Lunch
1:30 PM - 4:30 PM: OOS Investigation Process
- Identifying and assessing OOS test results
- Phase I: Laboratory Investigation
- Phase II: Full Scale OOS Investigation
- Conclusion and Documentation
- Identify root causes
- Determine CAPA and follow-ups
8:30 AM - 12:00 PM: Understanding OOT/Atypical and Documentation
- Recognize different types of OOT results
- Determine course of actions to process
- Understand cross-functional investigation
- Determine Key Performance Indicators (KPI) to monitor process
- Establish documentation and performance metrics
Meet Your Instructor
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.
She is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and will be their 2013 President. She is the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP Impurities of Drug Products Expert Panel (2012-15). She was also a member of USP General Chapter Expert Committee (2010-15), member of USP Reference Standard Project Team and USP Prescription/Non-Prescription Stakeholder Forum of previous cycle. She was a member of the Consumer Healthcare Product Association’s (CHPA) Stability and Impurities Breakout Groups. She currently is a member of AAPS Publication Committee, Chair of the Stability Focus Group and serves on the Steering Committees of CMC and Pharmaceutical Trace Impurities Focus Groups. She is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award.
She has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. 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"
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