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present
“Ensuring the Integrity of the Supply Chain”
On-Demand Webinar
This Webinar will educate the industry about the importance of
ensuring quality throughout the supply chain, focusing on
supplier/manufacturer relationships and new paradigms for addressing
safety concerns and GMP compliance.
OBJECTIVES: Understand need to qualify suppliers as well as
ensure ingredient compliance with specifications. Understand role of
quality agreements in addition to supply agreements as a tool for
ensuring GMP compliance and safety of ingredients. Understand utility of
industry cooperation to define and provide models for a comprehensive
approach to supply chain management, in support of government
initiatives for product safety and to support GMP compliance.
I. An Overview of the Issue:
- Maintaining consumer confidence in dietary supplements: GMP
requirements and the importance of a vendor qualification program
for ensuring integrity of the supply chain
- Implications of relying on “lowest cost” materials
- Learning from Experience: Case studies in the dietary supplement
arena
II. Manufacturer, supplier, and FDA perspectives on strengthening
existing systems:
- Component supplier quality risk management: The manufacturer’s
perspective
--Supply chain management (SCM), vendor qualification, change
control, documentation alignment (specifications, analytical
methods), supply agreements, quality agreements
- Achieving GMP compliance with your customers: The supplier’s perspective
- Qualifying suppliers and establishing quality agreements
- New Federal Action Plan: How it all comes together.
III. Questions and Answers
Speakers include:
- David Acheson, M.D., Assistant Commissioner for Food Protection, FDA
- Mike Bradley, Perrigo Company
- Bill H. Frankos, Ph.D., Director of the Division of Dietary Supplement
Programs, FDA
- Rick Perlman, American Society for Quality (ASQ)
- Andrew Shao, Ph.D., Council for Responsible Nutrition (CRN)
- Alexa Smith, International Pharmaceutical Excipients Council
(IPEC)
- Debbie Trinker, Kemin Health
- Dallas Wait, Gradient Corporation
To view presenter bios, click here
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