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 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.