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This webinar will introduce the concept of data integrity, compare data integrity from current regulatory guidance, establish the importance of data integrity to GMP for Excipient and look at practical ways to appropriately apply data integrity principles to excipient manufacturing. The webinar is for individuals involved with Regulatory Compliance, Quality Assurance, Quality Control, Production who have an appreciation of good documentation practices and GMP records and documents.
After attending this webinar, you will be able to:
- Define data integrity and establish its importance to GMP compliance
- Summarize the content of regulatory guidance
- Understand strategies for incorporating data integrity principles into excipient manufacturing
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.