Data Integrity Application and Implementation for Excipients and Excipient Suppliers

Wednesday, October 10, 2018 - 11:00am

Registration is closed, please select the links below to access the webcast

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.

Learning Objectives

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

Presenter(s)

Dale Carter

Dale headshot
Head of Quality
Evonik Industries

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.

Cancellation Policy

Note:

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3449 or email ipecamer@ipecamericas.org