ComplianceOnline

Establish Validation Protocol and Acceptance Criteria for Chromatographic Methods to Meet ICH Requirements

Instructor: Kim Huynh-Ba
Product ID: 701594
  • Duration: 90 Min
Purchase option for this webinar is currently unavailable. Please contact our Customer Care for more info.

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will discuss how to write validation protocol and determine acceptance criteria. It will also explain the systematic approach to validate analytical procedures.

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 assure analytical procedures are developed for its intended use and an understanding of validation requirements set forth by ICH, FDA, WHO and USP are very important.

This session will discuss:

  • Regulatory requirements
  • Present common deficiencies in relation to method validation
  • Critical factors of establishing a validation protocol for analytical procedures
  • Discuss important validation characteristics for chromatographic methods
  • How to determine acceptance criteria for the validation study

Areas Covered in the Webinar:

  • Regulatory Requirements for Analytical Test Methods
  • Understand cGMP requirements for analytical test methods.
  • Review ICH Q2 A&B guidelines for method development/validation.
  • Discuss critical points of FDA, WHO and USP validation guidelines
  • Understand lifecycle management of method validation
  • Designing Method Validation Protocol
  • Establish acceptance criteria for validatio

Who Will Benefit:

  • R&D analysts
  • QA and QC Managers
  • Regulatory scientists
  • Directors
  • Regulators
  • Researchers

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. 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).

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
ComplianceOnline Medical Device Summit 2017

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading