This workshop will be held virtually via the Zoom platform with frequent Breaks.
Schedule of Virtual Sessions
Monday, April 26 - 10:00am-12:00pm EDT
Tuesday, April 27 - 10:00am-4:00pm EDT
Wednesday, April 28 - 10:00am-4:00pm EDT
Thursday, April 29 - 10:00am-4:00pm EDT
Friday, April 30 - 10:00am-12:00pm EDT
Compliance with excipient GMP/GDP is important to everyone (not just auditors) involved in the manufacture, distribution or use of excipients. This workshop includes analyzing essential elements and expectations related to excipient good manufacturing practice and good distribution practices for materials intended for use in pharmaceuticals or dietary supplements. This workshop reviews the EXCiPACT Excipient GMP Certification scheme and the requirements of the updated NSF/IPEC/ANSI 363-2019.
After completing this hands-on, interactive workshop:
- Participants will be able to plan, conduct and document an audit of excipient manufacturing facilities for conformance to excipient GMP expectations.
- Excipient makers will be able to assess their conformance to industry standards and guides 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 guides including the EU Falsified Medicines Directive (FMD) Guideline for determining GMP for excipients.
- Participants will be able to identify and remediate deficiencies in data integrity.
This workshop is the best place to:
- Identify compliance expectations for excipient GMP/GDP
- Learn how to assess improvement needs at your own or your suppliers' facilities
- Learn how to ready your facility audit or certification audit
- Update your audit report-writing skills
- Learn how to develop reports to management to support GMP/GDP compliance
- Understand the current issues concerning the manufacture, distribution and use of excipients as identified by IPEC
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.
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.