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Pharmaceuticals, Medical Devices

Vendor Certification for Pharmaceutical Manufacturers

About the Course

A growing list of unsafe, counterfeit, contaminated, and defective products has emphasized the need for increased supplier quality management. This online training course discusses the regulations and standards for supply chain integrity. Topics in this course include: Origin, New Regulations, ICH Q10, Supplier Quality Agreements, and U.S. Food and Drug Administration (FDA) verses European Medicines Agency (EMA). After completing this training course, learners will be able to recognize regulations and guidances, identify critical supplier quality agreements and audits, and recognize the differences between FDA and EMA approaches to supplier quality.