Webinar - Excipient GMP Certification Scheme and Certification Body Qualification

Category: IPEC Federation
  • IPEC-Americas - 3138 10th Street N. Suite 500 - Arlington, VA 22201 - United States
  • 18 Nov 2021

Date: Thursday, November 18, 2021 - 16:00-17:00 CET - 10:00am-11:00am EST

This webinar is intended to provide an overview for use and value 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 procedure. The IPEC Guide was developed and designed to facilitate a consistent approach for excipient users to qualify an excipient-certification scheme owner (SO) and certification body (CB).

The webinar will cover the history and purpose for developing the IPEC guide, raise awareness of the need for a qualification process, and share examples for how the guide can be used by industry.

Learning/Awareness Objectives

During this webinar attendees will be provided with background and introduction to the IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients as well as the value for use of the guide from the perspective of a scheme owner, certification body, excipient supplier and excipient user.

Attendees will be provided with examples for:

  • how to qualify a 3rd party certifying body
  • how to know when an auditor is qualified to the standard
  • how to determine what certifying standard(s) might be right for them

Who should attend?

  • Excipient manufacturers, users, distributors
  • Regulatory affairs
  • Compendial affairs
  • Quality affairs
  • Regulatory authorities

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Presenters

Dr. Irwin Silverstein,  Lead Trainer and Consultant, IPEC-Americas Excipient Learning Lab

Dr. Iain Moore, Global Head of Quality Assurance, Croda International and President of the Board of EXCiPACT® asbl

Sophie Moreau, Lead Auditor and Product Manager Medical Device/Healthcare, SGS

Erika Vergara, Senior Business Quality Leader, Dow Chemical Company

Jeffrey Brambora, Global Senior GMP Auditor, Novartis Pharma AG – Basel, Switzerland

Priscilla Zawislak, Global Regulatory Affairs Advocacy Manager, IFF

 

Registration Fees
IPEC Europe and IPEC-Americas Members: FREE OF CHARGE
IPEC Europe and IPEC-Americas Non Members: 59$

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Cancellation Policy

Note:

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

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

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3449 or email ipecamer@ipecamericas.org