Course Number: 209

FDA New Guidance on Analytical Procedures and Method Validation for Drugs and Biologics

Live, Interactive Training Webinar

Date: Wednesday January 30, 2019 - 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In July, 2015, FDA finalized and issued the February 19, 2014 draft guidance on “Analytical Procedures and Methods Validation for Drugs and Biologics”. This guidance replaces the 2000 draft guidance on “Analytical Procedures and Method Validation” and a similar guidance issued in 1987. One important change is the inclusion of biologics in this guidance. More broadly, over this span of 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. In this presentation we will review the current guidance in the context of FDA’s current approach to the whole topic of validation and probe how this might impact the thinking behind the selection of methods and acceptance criteria for material characterization and the presentation of this information in regulatory filings.

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
- New expectations related to the verification of compendial methodology
- Method development and validation in the context of life-cycle management
- Critical quality attributes and critical process parameters as they relate to method selection, validation and control

Webinar outline and time breakdown:

Time*
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

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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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