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Enforcement Risk Reduction Approaches for FDA-Regulated Manufacturers

Supplier Management: Improving Supplier Oversight and Product Quality Outcomes

April 28, 2010


Speakers for this event:
 
  • John C. (Jack) Garvey, Principal, Compliance Architects ®   Learn More
  • Peter Miller, Senior Partner, Dynamic Compliance Solutions, Inc.  Learn More
  • This webinar will provide a review of real-world supplier management issues, along with innovative solutions, presented by two experts in the field.

    The program will explore the issues related to managing the supplier relationship and describe cost effective ways to improve supplier oversight that would complement any traditional supplier auditing program.

    The webinar will also explore how risk management should be integrated into an existing supplier management program.

    Finally, viewers will learn how these innovative approaches will positively affect product quality outcomes and lead to continuous product quality improvement.

    THIS PROGRAM IS INTENDED FOR:

    VPs, Directors, Associate Directors, and Managers of:

    • Quality
    • Quality Assurance
    • Regulatory Compliance

    for Pharmaceutical Companies and Medical Device Manufacturers

    ABOUT OUR SPEAKERS:

    John C. (Jack) Garvey, Principal, Compliance Architects ®

    John C. (Jack) Garvey, Esq., founder of Compliance Architects®, is an accomplished, broad-based FDA regulatory and compliance executive with over 25 years of experience developing and leading quality, regulatory and compliance initiatives at top FDA-regulated companies. In recent years, Jack has focused on compliance and quality strategy development and deployment for leading life-science companies.

     

    In addition to experience gained through roles of increasing responsibility and accomplishment at Accenture, Johnson & Johnson, BASF, and C. R. Bard, Jack’s dual background in law and engineering provides unparalleled ability to resolve today’s complex regulatory, quality and compliance issues.

     

    Jack’s extensive GMP, QSR, GLP, & regulatory compliance experience includes quality systems development and re-structuring, inspection preparation, clinical compliance, and FDA-483 and Warning Letter response planning. Operational experience includes directing international, project-based teams in matrix environments on supply-chain and compliance harmonization activities and hands-on experience applying operational excellence methodologies to regulated operations. Jack’s business-focused legal experience includes commercial, regulatory and litigation experience.

     

    Peter Miller, Senior Partner, Dynamic Compliance Solutions, Inc.

    Peter Miller, a Senior Partner with Dynamic Compliance Solutions, Inc., has implemented numerous Audit Programs in Small, Medium and Large scale Pharmaceutical and Medical Device organizations.

     

    Over the past 21 years, he has successfully structured these programs for maximum efficiency and benefit to the owner organizations. By working with the Parenteral Drug Association Audit Guidance Advisory Board over the past two years, Peter has been selected by the PDA to chair the new Standard Audit Criteria Task Force. He has extensive experience in the implementation of cost effective Quality Systems for small, medium & large scale Pharmaceutical and Biotech companies.

    ABOUT OUR SPONSORING PARTNER:
    Business Intelligence Solutions provides flexible and cost effective Quality Management Solutions for Life Science and FDA regulated companies. Ensuring your procedures and documentation meet current FDA regulations is difficult – especially trying to stay abreast of all the changes and how these affect your company. Business Intelligence Solutions provides software and consulting services that help ensure your company stays consistent, concurrent and compliant with all appropriate FDA regulations.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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