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Develop a Compliant Validation Protocol and Analytical Procedures according to the FDA Guidance and USP Good Documentation Practices
Instructor:
Kim Huynh-Ba
Product ID: 705740
Product ID: 705740
- Duration: 90 Min
This Method validation protocol training will discuss the regulatory requirements of analytical test methods, the USP good documentation practices <1029> and how to establish acceptance criteria for validation.
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Why Should You Attend:
New medicines are developed every day to meet medical needs. Analytical procedures are used to assure that the drug product meets applicable standards of identity, strength, quality, and purity during its shelf-life. Therefore, validation is a critical process to assuring analytical procedures are documented for its intended use set forth by ICH, FDA, and USP.
This session will discuss the critical aspects of a method validation protocol according to the USP Good Documentation Practices General Chapter <1029> and to construct the analytical procedure required by the most recent FDA analytical validation guidance.
Areas Covered in the Webinar:
- Discuss GMP regulatory requirements for Analytical Test Methods
- Familiarize with FDA requirements of analytical procedures
- Development of method validation protocols
- Understand USP Good Documentation Practices <1029>
- Discuss lifecycle management of method validation
- Establish acceptance criteria for validation
Who Will Benefit:
- R&D Analysts
- QA and QC Managers
- Regulatory Scientists
- Directors
- Regulators
- Manufacturers
- Laboratory Managers
- Quality Managers and Personnel
- Regulatory Affairs

Kim Huynh-Ba
Founder and Technical 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" (2010).
More Trainings by Expert
Stability Program to Support Shipping and Distribution of Drug Products
To Validate or Not To Validate: A Daily Question for the Pharmaceutical Scientist
Establish Change Control for Pharmaceutical Stability Program
GMP Requirements for Validation and Re-Validation of Analytical Procedures
Refund Policy
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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