Validation for Pharmaceutical Excipients

Wednesday, January 18, 2017 - 11:00am

Validation (aka continuous verification) is a requirement of the ANSI 363 and EXCiPACT Standards for Excipient GMP. This webinar will answer questions such as:

  • How does a company provide IQ/OQ/PQ documentation for equipment that has been used for many years?
  • How does a company develop the required documentation for process, cleaning, computer system and analytical validation for these long-established manufacturing operations?

Get the answers to these questions, which will appear in a new IPEC Americas guide to assist excipient manufacturers in the planning, execution and documentation of validation activities in all these areas.

Presentation Objectives

In this webinar participants will gain the knowledge and skills to develop, compile, and communicate validation documentation that meets the needs of the customer and the requirements of the standard.

In addition, you will learn:

  • Pragmatic approaches to successfully validate excipient operations. 
  • Using common chemical industry practices, terms and work products to build your qualification and validation documentation. 
  • Bridging the gap between the chemical industry approach to commissioning and qualifying a process to the documentation and work products that would be typically expected by the pharmaceutical customer and the FDA. 
  • Responding to audit queries concerning qualification and validation.

Presenter(s)

Katherine Ulman

KLU Consulting, LLC

Katherine Ulman recently retired from Dow Corning Corporation, now a wholly owned subsidiary of The Dow Chemical Company, after more than 40 years of employment. There she held positions as a global regulatory compliance manager for their Healthcare business as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site. She is currently an active member and vice chair of the Regulatory Committee for IPEC-Americas as well as a member of their executive committee. Ulman earned her Bachelor of Science degree in chemistry from the South Dakota School of Mines and Technology.

Cancellation Policy

Must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street
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 are unable to attend the webinar, a recording of the webinar will be provided to all registered persons.

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

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org