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Day 5



  • Irwin B. Silverstein, Ph.D.

    Lead Trainer and Consultant
    IPEC-Americas Excipient Learning Lab

    Irwin is a consultant to IPEC-Americas 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. Irwin participated in the development of both the IPEC-PQG Excipient GMP Guide and the NSF/IPEC/ANSI 363 Good Manufacturing Practices (GMPs) for Pharmaceutical Excipient Standard.

  • Sidney A. Goode

    IPEC-Americas Excipient Learning Lab

    Sidney A. Goode Pharm D, RPhworked 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.

December 3, 2021
Fri 10:00 AM EST

Duration 2H 0M

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