Course Description:

New medicines are developed every day to meet medical needs and improve quality of life and HPLC methods are widely used in R&D and QC pharmaceutical labs. Analytical methods establish acceptance criteria and monitor quality of drug products throughout their expiry. Therefore, validation becomes a critical process and it is important to understand requirements set forth by multiple regulatory agencies such as the ICH and the FDA.

This course will discuss different aspects of method validation, verification and transfer throughout the life cycle using Quality by Design approach (QbD). It will provide participants with an understanding of regulatory requirements in these areas. It will present critical principles of the transfer process, discuss different strategies and key factors that would influence the transfer, evaluate transfer packages and suggest how to handle transfer failures.

This 2-day comprehensive course will also discuss how to write protocol, establish acceptance criteria and document validation reports.

Learning Objective:

Upon completing this course participants will:

  • Understand GMP requirements for method validation
  • Understand ICH guidelines for validation of analytical procedures
  • Understand strategy options to transfer analytical procedures
  • Design validation protocol for analytical methods
  • Justify acceptance criteria for method validation
  • Understand stability indicating methods
  • Understand specificity and forced degradation studies
  • Implement validation protocols
  • Compile an effective validation report
  • Handle validation failures
  • Understand verification of pharmacopeia methods

Who will Benefit:

This course will benefit professionals involved in working with analytical methods of pharmaceutical products and management involved in making technical decisions in drug development. This includes but not limited to the following individuals:

  • QA/QC analytical chemists
  • QA/QC directors, managers
  • Investigators in QA/QC
  • R&D scientists
  • Project management
  • Manufacturing personnel
  • CROs analysts
  • Technical liaison
  • Regulatory affairs personnel
  • CMC specialists
  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Quality auditors
  • Document control specialists

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

I. Regulatory expectations of Method Validation
  1. Current review of critical GMP issues in analytical labs
  2. Common 483s observations and Warning Letters
  3. Review ICH Q2 A&B guidelines
  4. USP <1225> and <1226> requirements
  5. Analytical Method Life Cycle
Interactive Exercise and Discussion: Discuss Warning Letters and 483 violations on method validation

II. Development of stability indicating test methods
  1. Discuss validation characteristics
  2. Stress testing and forced degradation studies
  3. Discuss Q3 for impurities monitoring
  4. Validation process and method Life Cycle
Interactive Exercise and Discussion: Establish method validation protocol for typical drug product

III. Method Transfer Process
  1. Purpose of Analytical Method Transfer
  2. USP <1224> and Strategies of Method Transfer
  3. Phases of Method Transfer
  4. Determine Gap Analysis
Interactive Exercise: Establish checklist for gap analysis

IV. Relationship of Validation, Verification and Transfer
  1. Discuss the relationship
  2. Writing validation protocols and reports
  3. Determine acceptance criteria
Interactive Exercise and Discussion: Determine validation strategy for new product

Meet Your Instructor

Kim Huynh-Ba
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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