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Short Course

Course Information
Course Title: Keeping Your Analytical Method in Compliance: Validation, Verification and Transfer of Analytical Methods for Pharmaceutical Products
Categories: 1 - Liquid Chromatography
2 - Pharmaceutical Sciences
3 - Data Management
4 - Quality/Regulatory/Compliance
5 - Validation
Instructor(s): Kim Huynh-Ba Course Number: 78
Affiliation: Pharmalytik
Course Date: 03/09/2016 - Wednesday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $550 ($750 after 2/12/16) Textbook Fee:

Course Description
New medicines are developed every day to meet medical needs and improve quality of life. Analytical methods are widely used in R&D and QC pharmaceutical labs to monitor quality of drug products throughout their expiration dating period. Therefore, keeping the analytical method in compliance with validation requirements and product changes is a challenge for analytical scientists. This course will review the current regulations, provide updates from FDA, ICH, USP, and WHO, and different aspects of validation throughout development phases to establish critical acceptance criteria. It will also discuss different strategies and key factors that influence method transfer and avoid transfer failures. Participants should expect to share their experiences and discuss Best Practices to keep method stay in compliance. Textbook (optional): Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices, Kim Huynh-Ba (ed.) (Springer, 2008).

Target Audience
Analytical chemists, QA/QC scientists, R&D, project management, CROs, technical liaisons, regulatory scientists, laboratory auditors, who involve with generating, reviewing, evaluating analytical results of pharmaceutical products. Must have at least 2-year experience in pharmaceutical industry to fully participate. Not intended for microbiologists.

Course Outline
A. Regulatory expectations of Method Validation
* Current review of critical GMP issues in analytical labs
* Common 483s observations and warning letters
* Review ICH Q2 A&B guidelines
* USP <1225> and <1226> requirements
B. Development of stability indicating test methods
* Discuss validation characteristics
* Stress testing and forced degradation studies
* Discuss Q3 for impurities monitoring
* Validation process and method Lifecycle
C. Method Transfer Process
* Purpose of Analytical Method Transfer
* USP <1224> and Strategies of Method Transfer
* Phases of Method Transfer
* Determine Gap Analysis
D. Relationship of Validation, Verification and Transfer
* Discuss the relationship
* Writing validation protocols
* Determine acceptance criteria
* Handle validation failures

Course Instructor's Biography
Kim Huynh-Ba is the Executive Director of Pharmalytik Consulting and Training (www.pharmalytik.com). She provides consulting and training services to pharmaceutical companies, including those operating under FDA’s Consent Decree. She has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She took a sabbatical assignment while at Pharmalytik to join the U.S. Pharmacopeia (USP) Convention as the Director of Pharmacopeial Education Department, which provide training and education worldwide. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology, teaching pharmaceutical analysis, quality audit and analytical chemistry using both on-line and in-person format. Kim is also an instructor on cGMP compliance and quality topics for several global organizations such as ACS, AAPS, Pittsburgh Conference, and USP. Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. Recently, she has been elected to the USP Council of Experts (2015-2020), and currently participating in the USP Good Documentation Practices Expert Panel and USP Impurities of Drug Products Expert Panel. Kim is also an Alternate Councilor of ACS-DE section. Kim is an accomplished author and speaker of the compliance and quality areas, both domestic and internationally. 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) published by Springer.