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

Owner and Compendial Consultant
Global Pharmacopoeia Solutions LLC

J. Mark Wiggins is Owner and Compendial Consultant with Global Pharmacopoeia Solutions LLC, which he formed after more than 30 years’ experience in the pharmaceutical industry. He was previously Director of Compendial Affairs at Merck & Co., Inc., (known as MSD outside the US and Canada), with more than 15 years’ experience submitting new and revised monographs to pharmacopoeias, as well as reviewing and responding to proposed compendial changes from around the world. Mr. Wiggins also has experience in the testing and release of excipients for use in formulation design, scale-up, and clinical supplies in support of new product research and development, and 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 pharmaceutical industry associations in the US, UK, Europe, Japan and China, and represented PhRMA on the ICH Q4B activities to harmonize general chapters in the pharmacopoeias. Mr. Wiggins has authored several papers, including an introduction to the concept of the "Ideal Pharmacopoeia", "Compendial Globalization", and the industry perspective on the pilot project to achieve “Prospective Harmonization” for API monographs. He has also co-authored a comprehensive series of twelve articles on pharmacopoeia compliance that have been published as on-line regulatory sourcebooks for the journals Pharmaceutical Technology and BioPharm International. He has been an invited speaker at international meetings and conferences on compendial harmonization, including the Ph. Eur. workshop "Quality of Medicines in a Globalized World", and more recently in discussions with the pharmacopoeias and regulators in the US, UK, Europe, India, Japan, Korea, and China. Mr. Wiggins holds B.S. and M.S. degrees in Chemistry from Trinity University and the University of Wisconsin, both in the US.

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