CfPA and IPEC-Americas Co-Sponsor: Excipients: Compliance with Compendial and GMP Requirements

Monday, March 11, 2019 - 8:00am
Location: 

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 pharmacopoeias, and concludes with an exploration of approaches to compendial surveillance, opportunities for advocacy, and ultimately, compliance with the requirements in the pharmacopoeias.”

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 

Presenter(s)

Irwin B. Silverstein

Lead Trainer
IPEC-Americas Excipient Learning Lab

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. He has worked since 1991 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 recent consulting has broadened to include pharmaceutical firms where he assesses conformance to site requirements. He has audited excipient manufacturers to perform a gap analysis with respect to excipient GMP compliance and has provided detailed guidance as to how to improve their conformance to excipient GMP requirements. As an experienced GMP auditor, with American Society for Quality (ASQ) Certified Quality Auditor (CQA) status as well as ISO 9000 Certified Lead Auditor training, he has developed the IPEC-Americas auditor training programs for hourly and supervisory personnel. Irwin is also serving as leader of the IPEC-Americas Excipient Learning Lab (ELL).

Cancellation Policy

Must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Workshops
3138 10th Street
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees (less 5% non-refundable service fee) are refundable if cancellation is received at least three weeks (21 calendar days) prior to workshop start date (less service fees). Cancellations received thereafter are non-refundable. Registrations are transferable to other company representatives if requested via mail or e-mail up to 5 business days before the workshop.

IPEC-AMERICAS IS NOT RESPONSIBLE FOR ANY TRAVEL EXPENSES OR FEES INCURRED BY PARTICIPANTS. WORKSHOPS WILL BE CONFIRMED NO LATER THAN 3 WEEKS PRIOR TO SCHEDULED START DATE.