91AV

Introduction

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



Note: Use coupon code 232082 and get 10% off on registration.

Speakers

• 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", United States

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Venue

Madison

Madison, Madison, Madison, 53705, United States

Useful links

Committee

• ComplianceOnline Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
  
  Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
  
  Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
  
  Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference., United States

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Organised by

ComplianceOnline

ComplianceOnline

Contact information

Chandrakala R
ComplianceOnline
2600 E. Bayshore Road
6506203915
Contact us by email

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