Pharmaceutical and Medical Device Supplier Quality Management

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

After this course learners will be able to identify regulator concerns about supply chain quality recognize new regulations and guidances coming into effect. identify critical supplier quality agreements and audits. recognize the differences between u.s. fda and ema approaches to supplier quality.