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.
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
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.