A Practical Guide to Excipient Risk Assessments

Wednesday, April 19, 2017 - 11:00am

Formal Risk Assessments are required to comply with both NSF/IPEC/ANSI 363 and EXCiPACT Excipient Good Manufacturing Practices. Do YOU know why and how to perform them?

This is a practical introduction to the whys and how-tos of conducting risk assessments for excipients.

Presentation Objectives

By attending this webinar, participants will:

  • Obtain background on risk assessment in the EXCiPACT™ and NSF/IPEC/ANSI 363 Excipient GMPs
  • Learn where, on a section-by-section basis, risk assessments are required for both these standards
  • Understand step-by-step procedures for performing and documenting various types of risk assessments
  • Understand the broad financial implications of performing risk assessments

Presenter(s)

Dale Carter

Dale headshot
Head of Quality
Evonik Industries

Dale graduated with a BS in Chemistry from Davidson College in 1983 and an MS in Chemistry from North Carolina State University in 1988. From 2000 he spent 8 years as Manager, Product Quality & Management Systems at the Archer Daniels Midland Company in global food processing and commodities trading. From 2008 – August 2017, Dale was Global Director of Quality at the JM Huber Engineer Materials Silica Business Unit. Following the Huber acquisition by Evonik Industries on 1st September, 2017 he became Head of Quality BL Silica NAFTA responsible for the North America region where Evonik has a combination of 6 Silica plants.

Dale represented JM Huber as a member of the IPEC-Americas. He was a member of the GMP Committee from 2001 – 2010 and as Chairman from 2011-2013, During this time, he was a member of the EXCiPACT project team and he became a Board Director of EXCiPACT asbl in February 2017 representing IPEC-Americas.

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