Course Number: 209

FDA Guidance on Analytical Procedures and Method Validation and its Relationship to Upcoming ICH Q2 and USP <1220> Initiatives

Live, Interactive Training Webinar

Date: Wednesday February 5, 2020 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Anthony J. DeStefano Ph.D.
(Former USP Sr. Vice President of General Chapters and Healthcare Quality Standards) Biography>>>

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In July, 2015, FDA issued its Guidance “Analytical Procedures and Methods Validation for Drugs and Biologics”. Over time, FDA has modified its approach to method validation from quite prescriptive to a reliance on risk management and a deep understanding of the purpose, science and statistics of control behind each of the characterization tests. The approach FDA takes in their guidance foreshadows and dovetails with ICH initiatives Q2(R2) and Q14 (Analytical Procedure Development and Revision of Q2(R1) Analytical Validation) and the draft United States Pharmacopeia General Chapter <1220> - The Analytical Procedure Lifecycle. In this presentation we will review the current guidance in the context of FDA, USP and ICH current approaches to the topic of validation and concepts such as the Analytical Target Profile, systematic method development and method and product lifecycle management.

Learning Benefits:
- Review the current FDA guidance on Analytical Procedures and Method Validation
- An in-depth discussion of the guidance in light of FDA’s approach to method development and validation
- A discussion of a science-based approach to the selection of methodology of material characterization and subsequent method validation, including updates to ICH Q2(R2) and ICH Q14 initiatives
- New expectations related to the verification of compendial methodology
- Method development and validation in the context of life-cycle management, including USP General Chapter <1220>
- Critical quality attributes and critical process parameters as they relate to method selection, validation and control

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Live Lecture Part 1,
11:30 AM Break
11:40 AM Live Lecture Part 2,
12:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Analytical Chemists
  • Laboratory Management
  • Regulatory Compliance Managers
  • Quality Control and Assurance Personnel
  • Chemical Manufacturing and Control (CMC) Personnel

Registration Form ►

Instructor: Anthony J. DeStefano Ph.D. 
Consultant - Former USP Sr. Vice President of General Chapters and Healthcare Quality Standards

Tony DeStefano began his career at Procter & Gamble in mass spectrometry. After P&G acquired Norwich Eaton Pharmaceuticals, he managed Physical Measurement and Method Development Sections for several years, after which he established Norwich’s first Bioanalytical Section. In 2002, he returned to Cincinnati to manage the bioanalysis programs for multiple clinical studies. He has spoken and written extensively in the areas of regulated bioanalysis and analytical and bioanalytical validation and outsourcing. In 2008 he joined the US Pharmacopeia as its Vice President of General Chapters. At USP, he led initiatives to maintain, update and redesign its General Chapters. He was promoted to Senior Vice President and had responsibility for the Health Care Quality Standards, Excipients, Dietary Supplements and Food Ingredients groups. He was a USP representative to the ICH Q3D Expert Working Group on metal impurities and the Pharmacopoeial Discussion Group (PDG). The purpose of the PDG, with representatives from the European Pharmacopoeia, the Japanese Pharmacopoeia, the U.S. Pharmacopeia and the World Health Organization as an observer, is to harmonize pharmacopeial standards (excipient monographs and selected general chapters, including elemental impurities) in three major regions of the world. While at USP, he lead the effort to replace USP Heavy Metals <231> with the new general chapters <232> and <233>. He has spoken extensively regarding these chapters both domestically and internationally. He was a co-developer of the initial USP training course on elemental impurities and served as the trainer for the first session. He is currently a consultant through YourEncore and Nuventra, and personally, consulting on analytical, bioanalytical, compendial and quality-related issues. He is a member of the American Chemical Society (ACS), Chair of the Board of the Product Quality Research Institute (PQRI), and a past president of the American Association of Pharmaceutical Scientists (AAPS)...


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