A Practical Guide to Excipient Risk Assessments

Wednesday, April 19, 2017 - 11:00am to 1:00pm

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
  • Know on a section-by-section basis where risk assessments are required for both of these standards
  • Understand step-by-step procedures for performing and documenting risk assessments
  • Understand the broad financial and liability implications of performing risk assessments

Presenter(s)

Dale Carter

Dale headshot
Director, Global Quality
J M Huber, Engineered Materials, Silica Business unit

Dale is the Global Director of Quality for the Silica Business Unit of Huber Engineered Materials and past chair of IPEC-Americas. He is responsible for quality systems, product quality and compliance with IPEC/PQG GMPs for the manufacturing of Silica products at facilities in Tennessee, Maryland, India, Finland, and China. Dale has been performing risk assessments for over 20 years in both food and pharmaceutical ingredients. He has been a member of the EXCiPACT ™ Board and NSF Joint Committee on Pharmaceutical Excipients.

Prior to joining Huber, he was the Manager, Product Quality and Management Systems in the Office of Compliance and Ethics for the Archer Daniels Midland Company where he supported processing and business operations in the development and improvement of quality management systems to ensure sustainable quality, regulatory compliance, effective risk management, and customer satisfaction. While with ADM he supported excipients, bulk APIs, food ingredients, dietary supplement ingredients, biofuels, animal feeds, and specialty grains products.

He holds a Bachelor of Science degree from Davidson College in Chemistry and a Master of Science degree in Chemistry from North Carolina State University.

 

Cancellation Policy

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

IPEC-Americas Webinars
3138 10th Street
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 are unable to attend the webinar, a recording of the webinar will be provided to all registered persons.

Note: No cancellations are available for archived webinars. Recordings are available for 21 days after purchase.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org