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IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients

Category: IPEC Federation
  • Webinar - IPEC-Americas - Arlington, VA - United States
  • 17 Nov 2020

DESCRIPTION

The presenters will provide an overview of the recently published IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients.

Lack of a unified industry approach to certification body qualification has resulted in pharmaceutical companies independently developing their own approach, which is subject to scrutiny during regulatory agency inspections. This Guide facilitates a consistent approach by excipient users to the qualification of an excipient-certification scheme owner (SO) and certification body (CB). This webinar will present the minimum criteria for the qualification of an excipient-certification SO and CB, which should be useful to excipient users in their own qualification of the GMP certificates issued by a CB.

LEARNING OBJECTIVES

Attendees will be able to:

  • Define minimum qualification criteria for an excipient-certification SO and CB.
  • Identify minimum information needed by excipient users to qualify a SO as well as the CBs who conduct and issue excipient GMP certificates and audit reports.
  • Become familiar with content and use of the template associated with the Guide.

DATE AND TIME

Tuesday 17 November 2020 - 9:30 EST / 14:30 GMT / 15:30 CET


REGISTRATION FEES

IPEC Federation Member companies: FREE (applicable to IPEC Europe Members)
IPEC Federation Non Member companies: $ 59


PRESENTERS

Dr. Irwin B. Silverstein – Lead Trainer and Consultant, 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.

Jeffrey Brambora – Global Senior GMP Auditor, Novartis Pharma AG – Basel, Switzerland
Jeffrey is a quality lead auditor with nearly two decades of international GMP auditing experience. He has co-authored the United States national standard for excipient GMP (NSF/IPEC/ANSI 363) as well as the EXCiPACT standards for excipient GMP and GDP.