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Excipients: Compliance with Compendial and GMP Requirements
March 11-12, 2019
New Brunswick, NJ
Course Offering 190311NJ2795
Course ID 2795
Who Should Attend?
This course is intended for those responsible for ensuring compliance of excipients with the pharmacopoeias and regulatory authorities, and is applicable to pharmaceutical and excipient manufacturers and excipient distributors within the OTC, generic, innovator, biotechnology, consumer-care, and related industries. This course will benefit individuals in:
• Compendial affairs
• Regulatory affairs/CMC
• Quality assurance/Quality control
• Analytical chemistry
• R&D/product development/Formulation/Method development
• Product management/marketing
Co-sponsored by IPEC-Americas
and The Center for Professional Advancement (CfPA); partners in training and education (T&E).
Irwin Silverstein, Ph.D., Consultant to the pharmaceutical industry
Irwin Silverstein has been a consultant to the pharmaceutical industry since 2000. His career included 17 years as the head of corporate quality for ISP, a specialty chemical manufacturer that produced excipients and Active Pharmaceutical Ingredients. Since leaving ISP, he works as a consultant and was the Chief Operating Officer of International Pharmaceutical Excipients Auditing (IPEA) from incorporation until sale in 2014. During this time, IPEA was accredited by ANSI for their Excipient GMP Conformance Certification Program. He has been a subcontractor to a consulting firm hired as expert consultants by pharmaceutical firms in consent decree with FDA. Currently, he has continued to work with the International Pharmaceutical Excipients Council of the Americas (IPEC) since their founding in 1991 and has been involved in the development of excipient GMPs and related guidelines. He is on the NSF Standards Writing Committee that developed the NSF/IPEC/ANSI 363 Good Manufacturing Practices for Pharmaceutical Excipients ANSI standard. He is also the chair of the IPEC Learning Lab with responsibility for development of synchronous and asynchronous learning including workshops, webinars and eLearning.
Dr. Silverstein has authored many articles on excipient GMP compliance in magazines such as Pharmaceutical Technology, Tablets and Capsules, and Pharmaceutical Outsourcing. He has been a frequent presenter at conferences involving excipient regulatory compliance including ExcipientFest, ASQ Spring Conference, IVT and RAPs. He possesses a Ph.D. in organic chemistry and is an ASQ Certified Quality Auditor (CQA).
J. Mark Wiggins is Director of Compendial Compliance and Advocacy at Merck & Co., Inc., with over 30 years’ experience in the pharmaceutical industry. His current responsibilities include ensuring compliance with compendial requirements, preparing and submitting new and revised monographs to the pharmacopoeias, and reviewing/responding to proposed compendial changes from 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. Mr. Wiggins has been an active participant in compendial harmonization efforts, serving as representative on ICH Q4B, and leading face-to-face meetings with pharmacopoeias. He has been an invited speaker and published articles on compendial harmonization and excipient compliance. Mr. Wiggins holds degrees in Chemistry from Trinity University and the University of Wisconsin.
The Heldrich Hotel
10 Livingston Avenue
New Brunswick , NJ
Website: The Heldrich Hotel
PLEASE NOTE: Participants must make their own reservations; the cost of
hotel accommodation is not included in the course fee. Final hotel information
will be emailed to you in your confirmation package approximately 3 weeks
prior to the course start date.