Dow Diamond Center (Houston Area)
270 Abner Jackson Parkway
Lake Jackson, TX 77566
This workshop includes analyzing the essential elements of and expectations related to excipient good manufacturing practice and good distribution practices for materials intended for use in pharmaceuticals or dietary supplements.
Participants will be able to plan, conduct and document an audit of excipient manufacturing facilities for conformance to excipient GMP/GDP expectations.
Excipient makers will be able to assess their conformance to industry standards such as NSF/IPEC/ANSI 363, EXCiPACT and the IPEC PQG GMP Guide and remediate any gaps.
Excipient users will be able to: assess their suppliers for adequate conformance to industry standards, and address the EU Falsified Medicines Directive (FMD) Guideline on the formalized risk assessment for determining the appropriate good manufacturing practice for excipients of medicinal products for human use.
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. He has worked since 1991 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. Dr. Silverstein established an excipient GMP certification program that was accredited by the American National Standards Institute (ANSI) and ran the program from 2001 till 2014.
His recent consulting has broadened to include pharmaceutical firms where he assesses conformance to site requirements. He has audited excipient manufacturers to perform a gap analysis with respect to excipient GMP compliance and has provided detailed guidance as to how to improve their conformance to excipient GMP requirements. As an experienced GMP auditor, with American Society for Quality (ASQ) Certified Quality Auditor (CQA) status as well as ISO 9000 Certified Lead Auditor training, he has developed the IPEC-Americas auditor training programs for hourly and supervisory personnel. Irwin is also serving as leader of the IPEC-Americas Excipient Learning Lab (ELL).
Sidney A. Goode Pharm D, RPh worked with Dow Chemical for thirty eight years, holding positions in chemical and toxicology research, product regulatory management, sales/marketing, FDA regulatory compliance management, quality and project management. He was also part of a team that supported the approval of products seeking regulatory acceptance for marketing; a member of the consolidated audit group qualifying and auditing suppliers, quality systems and regulatory compliance with industry standards. His career spanned intervals in the areas of industrial hygiene, medical department administration and environmental compliance. A decade was spent working part time as a co-director of a psychiatric hospital pharmacy participating in clinical trials of potential drugs and treatment regimens.
He is currently working as a consultant concentrating in areas of regulatory and quality compliance in the pharmaceutical, food and associated industries. His activities also include auditing work with International Pharmaceutical Excipient Auditing, IPEA Inc. (now operated by NSF International), and educational training through IPEC-Americas newly organized training committee. His training includes a BS degree in Biology/Chemistry, BS, Pharm D in Pharmacy, and certification in Clinical Toxicology. He has worked with International Pharmaceutical Excipient Council, IPEC, from early formation in the creation and publications of GMP and supporting guidance documents. He has held positions on the Board of Directors, and was chair of the GMP Committee for several terms.