Course Number: 208

Elemental Impurities Compliance for the Pharmaceutical Industry; Understanding and Implementing USP General Chapters <232> & <233> and A Review of ICH Q3D

Live, Interactive Training Webinar

Date: Wednesday November 20, 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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The USP General Chapter on Heavy Metals <231> first appeared in the USP in 1908. In 2005, the United States Pharmacopeia (USP) began the process of replacing the sulfide precipitation based Heavy Metals general chapter with atomic spectroscopy based standards. The resulting general chapters are <232> - Elemental Impurities – Limits and <233> - Elemental Impurities - Procedures. General chapter <232> is essentially harmonized with the ICH guideline Q3D, while general chapter <233> harmonization is being discussed by the Pharmacopeial Discussion Group. Both chapters have been implemented and compliance by USP and FDA is expected. These standards represent a dramatic departure from the venerable Heavy Metals test in that a specific list of elements and toxicologically-based limits is provided. Each element is associated with a specific permissible daily exposure limit (PDE’s) for oral, parenteral and inhalational routes of administration.

The subject is of importance to the manufacturers of new drug products as they are required to comply with the new elemental impurities standards either through risk assessments or through testing as new regulatory submissions are made, and to manufacturers of existing products as they make decisions regarding the extent of risk assessment and testing required to demonstrate compliance with the new standards. If the manufacturer’s compliance strategy involves testing, there are many things to consider regarding the selection of the correct analytical technique (e.g., atomic absorption, ICP emission spectroscopy, ICP mass spectrometry).

The objective of this live training webinar is to provide an understanding of the new USP standards and the ICH Q3D guideline, including new initiatives to correct an error with the cadmium inhalation-route value and to determine elements and permissible daily exposure limits for transdermal and cutaneous drug products. We will discuss what testing, documentation and rationale is required in order to comply with the spirit of the documents, how to perform a proper risk assessment, and how to perform suitable analytical measurements.

Learning Benefits:
-A review of ICH Q3D and an update on current revision initiatives
-An in-depth discussion of USP <232> and <233>
-Risk assessments
-Compliance strategies
-Updated review of key resources
-Analytical considerations and selecting the best technique
-Analytical method validation

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 Managers
  • Chemical Manufacturing and Control (CMC) Managers

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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)...

The FDA guidance on elemental impurities expects compliance with these general chapters for new drug products as of June 1, 2016 and for existing drug products as of January 1, 2018. Both chapters are implemented in the USP/NF via a General Notices requirement as of January 1, 2018.

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