Speaker Profile

Kim Huynh-Ba
Executive Director, PHARMALYTIK

Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She 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. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines.

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 (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.

Kim 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. Kim 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. Kim 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.

Kim 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

Speakers

Stability Program in Drug Development: A Comprehensive Approach

The objective of this web seminar is to provide a comprehensive overview of the approach used to establish an effective and compliant stability program for small molecule pharmaceuticals. Discussion will include a thorough review of cGMP regulations and ICH Stability guidelines, development stability testing protocol supporting global markets, and strategies to minimize redundant testing for resource saving.

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Speakers

Effective CAPA Program for GMP Operations

Having an effective CAPA documentation and tracking system are crucial to pharmaceutical operations. This system will allow personnel to identifying the root cause, corrective action taken, and verification stages.

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Speakers

Impact of Good Documentation Practices on Compliance Activities

Key components of documentation and record management system will be introduced. Regulatory requirements will also be discussed as the basis of documentation standards. It will also cover different types of records and how it would affect quality systems.

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Speakers

Effective CAPA Program for GMP Operations

Having an effective CAPA documentation and tracking system are crucial to pharmaceutical operations. This system will allow personnel to identifying the root cause, corrective action taken, and verification stages. This session will discuss important components to create an effective CAPA system, determine different levels of actions to be taken, and training needed to prevent reoccurrence.

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Speakers

Stability Program in Drug Development: A Comprehensive Approach

The objective of this web seminar is to provide a comprehensive overview of the approach used to establish an effective and compliant stability program for small molecule pharmaceuticals. Discussion will include a thorough review of cGMP regulations and ICH Stability guidelines, development stability testing protocol supporting global markets, and strategies to minimize redundant testing for resource saving.

View Details


Speakers

Impact of Good Documentation Practices on Compliance Activities

This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, efficacy and/or data integrity. Key components of documentation and record management system will be introduced. Regulatory requirements will also be discussed as the basis of documentation standards. It will also cover different types of records and how it would affect quality systems.

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