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.
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.
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.