The presentation focused on:
Most on-site audits of excipient suppliers have been suspended (deferred) due to the pandemic; however, on-going supplier assessments are still required.
Although it would be difficult, if not impossible, to perform a remote (virtual) audit to assess a new supplier/customer, a remote audit may be an acceptable alternative for a surveillance audit.
Recognizing the challenges that these remote audits bring; how can an auditor accomplish their objective to adequately evaluate (assess) a site? How can the auditee maximize the effectiveness of this approach? This webinar will offer suggestions to achieve these mutual objectives.
Presenter(s)
Irwin B. Silverstein, Ph.D.
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.
Ann Gulau
Ann’s background is in the field of Materials Science and Engineering. She spent 31 years working for The Dow Chemical Company, first in the R&D Department and later in the Quality function. She was first introduced to the concept of “good manufacturing practices” in 1999 and has worked with GMP products ever since. She has lead implementation of API, excipient and cosmetic ingredient GMP at multiple sites, and represented quality assurance for products sold as active ingredients, excipients, cosmetic ingredients, food additives and food contact materials.
Ann is currently working for DuPont Nutrition & Health as a business-level quality manager.
Ann joined IPEC-Americas in 2016 and is committee chair for the Excipient Qualification committee.
Lucien Sergile
Lucien (Luc) Sergile Jr. is a Quality Manager working for the Global Quality Auditing and Compliance Group at Eli Lilly and Company where he audits and monitors supply chain participants to support the global manufacturing of Lilly drug products and medical devices. Luc brings his expertise in GMP manufacturing and Supplier Oversight and knowledge to the table especially concerning data integrity when it comes to monitoring critical process parameters and ensuring the legitimacy and consistency of data with suppliers.
Luc also is a member of the IPEC Americas and Rx-360 and has helped author-auditing guides such as the IPEC GMP Audit Guide and the Rx-360 Data Integrity Audit Guide.