To Validate or Not To Validate: A Daily Question for the Pharmaceutical Scientist

Why Should You Attend:

New medicines are developed every day to meet medical needs and improve quality of life. Analytical procedures are used to establish acceptance criteria and monitor quality of drug products. Therefore, validation becomes a critical process especially with the changes throughout the drug development process. It is important to understand validation requirements set forth by ICH and FDA.

This 90-minute webinar will present the common deficiencies in relation to method validation, outline regulatory requirements and the change control process needed to stay in compliance.

Learning Objectives:

Upon completion of this session, attendees will learn key factors that would affect validation process of analytical procedures. One must understand validation characteristics and able to determine when re-validation would need to take place.

Areas Covered in the Webinar:

• Deficiencies related to method validation
• Factors affecting quality of medicines
• Validation characteristics
• Verification of analytical method
• Validation vs Re-validation plan
• Relationship of validation/revalidation

Who Will Benefit:

• Pharmaceutical scientists
• Manufacturers of raw materials and ingredients
• Analysts and lab managers
• QA managers and personnel
• Regulatory affairs

Instructor Profile:

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. 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 is also a short course instructor on cGMP compliance and quality topics for several global organizations such as ACS, 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 was their 2013 President. She is the Chair of USP Good Documentation Practices Expert Panel and a member of USP Impurities of Drug Products Expert Panel.

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” (2010).

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