New Brunswick, New Jersey
This course includes an introduction to the pharmacopoeias with an emphasis on the USP-NF and Ph. Eur. Details of the content, organization and use of the pharmacopoeias will covered, along with regulatory considerations for excipients. The course reviews practical examples of compliance with compendial requirements, as published by the major pharmacopoeias, and concludes with an exploration of approaches to compendial surveillance, opportunities for advocacy, and ultimately, compliance with the requirements in the pharmacopoeias.
Presenter(s)
Irwin B. Silverstein, Ph.D.
Irwin is a consultant to IPEC and the excipient industry specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.
For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. Since 1991, he has worked with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration. Dr. Silverstein established an excipient GMP certification program that was accredited by the American National Standards Institute (ANSI) and ran the program from 2001 till 2014.
His consulting also includes conformance assessments to site requirements for pharmaceutical manufacturers (finished drug makers). He performs gap analyses with respect to excipient GMP compliance for excipient manufacturers and has provided detailed guidance as to how to improve their conformance to excipient GMP requirements. He is an American Society for Quality (ASQ) Certified Quality Auditor (CQA) as well as ISO 9000 Certified Lead Auditor. He helped develop the IPEC-Americas auditor training programs for hourly and supervisory personnel. Irwin also serves as leader of the IPEC-Americas Excipient Learning Lab (ELL).
J. Mark Wiggins
J. Mark Wiggins , is a Director in Regulatory Policy and Compendial Affairs at Merck & Co., Inc., West Point, PA, U.S.A. (known as MSD outside the United States and Canada), with over 30 years’ experience in the pharmaceutical industry. His current responsibilities include preparing and submitting new and revised monographs to the pharmacopoeias for drug products, drug substances, and excipients, as well as reviewing and responding to proposed compendial changes published by pharmacopoeias around the world. Prior to his current position, Mr. Wiggins was responsible for testing and releasing excipients for use in formulation design, scale-up, and clinical supplies. He also has experience in the synthesis and characterization of active pharmaceutical ingredients for use in the treatment of HIV/AIDS, cancer, diabetes, hypercholesterolemia and depression.
Mr. Wiggins has been an active participant in compendial harmonization efforts, serving as PhRMA representative on the ICH Q4B Expert Working Group, and leading several face-to-face meetings with pharmacopoeias on the topic of harmonization. He is also an active contributor to several industry-based compendial discussion groups, and has chaired the US-based PhRMA compendial team, which has important connections with EFPIA, based in the EU. He has been an invited speaker in several international meetings, including presentations on compendial harmonization at the Ph. Eur. workshop on "Quality of Medicines in a Globalized World", and more recently at meetings with the pharmacopoeias and regulators in the US, Europe, India, Japan, Korea, and China.
Mr. Wiggins has authored several papers covering each area of his career. Recent articles include introductions to the concepts of the "Ideal Pharmacopoeia" and "Compendial Globalization", as well as the industry perspective on the pilot project to achieve “Prospective Harmonization” for API monographs. Mr. Wiggins holds degrees in Chemistry from Trinity University and the University of Wisconsin, both in the US.