Free registration for IPEC-Americas members.
The presenters will provide an overview on soon to be published IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients:
Lack of a unified industry approach to Certification Body (CB) qualification, results in each pharmaceutical company independently developing an approach, which would be subject to scrutiny during a regulatory agency inspection. Some pharmaceutical companies are reluctant to develop one on their own and without one are unwilling to accept 3rd party excipient GMP certification, which places additional audit burden on excipient manufacturers. This webinar will provide a method for qualification of Scheme Owners and Certification Bodies that excipient users will find useful in their selection of a Certification Body.
Attendees will be able to:
• Define qualification expectations for certification scheme (CS) owners and certification bodies (CBs)
• Identify information needed by excipient users to qualify CS Owners and CBs who conduct and issue excipient GMP certificates and audit reports
• Become familiar with content and use of the Qualification Template
Katherine Ulman 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.
Dr. Irwin B. Silverstein. Irwin is a consultant to IPEC and the excipient industry specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.
For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. Since 1991, he has worked with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration.