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
- 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
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.