Excipients: Compliance with Compendial and GMP Requirements

Thursday, March 19, 2020 (All day) to Friday, March 20, 2020 (All day)
Location: 

ExitCertified (Attune formerly Microtek)
Raritan Plaza III
105 Fieldcrest Avenue, Suite 405
Edison , New Jersey 08837
Phone: 800-207-9620 (for directions and parking info only)

 

There are several hotels within walking distance.

 

IPEA-Americas Members will receive a substantial discount off the listed prices. Please contact IPEC-Americas staff at ipecamer@ipecamericas.org for the discount code.


Course Description

Excipients often play a critical role in the manufacture of biopharmaceuticals and in the formulation of small molecule and biopharmaceutical products as well as, enabling delivery of medicines to the patients who need them. Companies that manufacture, distribute and use excipients must meet appropriate quality and regulatory requirements. The General Notices of the United States Pharmacopeia-National Formulary (USP-NF), states: “Official substances are prepared according to recognized principles of good manufacturing practice and from ingredients complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs.”

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Presenter(s)

Irwin B. Silverstein, Ph.D.

Lead Trainer
IPEC-Americas Excipient Learning Lab

Dr. Irwin B. Silverstein.  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.

J. Mark Wiggins

Director in Regulatory Policy and Compendial Affairs
Merck & Co., Inc.

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.

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