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 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.