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Excipient GMP Certification Scheme and Certification Body Qualification

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Contributors

  • 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.

  • Dr Iain Moore

    Global Head of Quality Assurance
    Croda International and President of the Board of EXCiPACT® asbl

    Iain has held a range of QA roles in Croda for over 25 years, including implementing ISO and GMP standards and hosting two regulatory inspections to API GMPs. He has contributed to the publication of the IPEC-PQG GMP Guide and European and US National Standards. He led the team that took the IPEC-PQG GMP Guide and converted it to the EXCiPACT Certification Scheme for Pharmaceutical Excipients. Iain is the current President of the Board of EXCiPACT asbl.

  • Sophie Moreau

    Lead Auditor and Product Manager Medical Device/Healthcare
    SGS

    Sophie Moreau has worked at SGS Belgium for 6 years, a certification body registered to certify against EXCiPACT standard. She is currently active in different healthcare and medical devices standards (EXCiPACT, EFFCI, ISO13485, …). Sophie has a Master in Biosciences Engineering and worked previous for GSK Biologicals, Baxter, Cenexi-Laboratoire Thissen in different QA roles, including supplier quality management.

  • Erika Vergara

    Senior Business Quality Leader
    Dow Chemical Company

    Erika’s background is in the field of manufacturing and engineering. She has served as Senior Business Quality Leader of Dow for the past 10 years, where she has helped to manage and increase customer satisfaction and excellence to manufacturing GMP products as APIs, excipients, food and cosmetics ingredients around the globe. Erika holds a Bachelor of Chemistry Degree in Industrial and Technological Attributions. She is also a Certified Quality Engineer (CQE) and Certified Manger of Quality/ Organizational Excellence (CQM-OE) by American Society for Quality (ASQ).

  • Jeffrey Brambora

    Global Senior GMP Auditor
    Novartis Pharma AG – Basel, Switzerland

    Jeffrey is a quality lead auditor with nearly two decades of international GMP auditing experience. He has co-authored the United States national standard for excipient GMP (NSF/IPEC/ANSI 363), the EXCiPACT standards for excipient GMP and GDP, and several IPEC guides.

  • Priscilla Zawislak

    Global Regulatory Affairs Advocacy Manager
    IFF

    Priscilla Zawislak is currently the Global Regulatory Affairs Advocacy Manager for IFF. She has over 35 years’ experience in regulatory affairs and quality for excipients, food additives and ingredients for personal care products. She is IPEC-Americas Immediate Past-Chair and is the current Vice President of the IPEC Federation.

November 18, 2021
Thu 10:00 AM EST

Duration 1H 0M

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