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 Carter is the Head of Quality for the Business Line Silica in the Region Americas for Evonik Industries. He is responsible for product quality and compliance with IPEC/PQG GMPs for the manufacturing of Silica products at facilities in Tennessee, Maryland, Pennsylvania, Alabama, and New York.  Dale is a Board member of EXCiPACT and a member of the NSF Joint Committee for Pharmaceutical Excipients that wrote the ANSI/NSF/IPEC/363 Good Manufacturing Practices for Pharmaceutical Excipients. He is a Past Chair of International Pharmaceutical Excipient Council of the Americas and currently serves as Vice Chair Membership.  Dale received an MS in Chemistry from North Carolina State University and a BS in Chemistry from Davidson College.  He is an ASQ Certified Quality Auditor.  Prior to joining Evonik/JM Huber Dale worked for Pfizer, The Coca-Cola Company, and Archer Daniels Midland Company.

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
571-814-3450 or email ipecamer@ipecamericas.org