Risk Management in Pharmaceutical Manufacturing

This course covers the practical application of risk management principles, published in “Guidance for Industry: Q9 Quality Risk Management”, through case studies applied to process design and manufacturing. Topics in this course include: Risk Assessment, Risk Control, Review and Communication, Validation Case Study, and Change Control Case Study. After completing this course, learners will be able to recognize risk management principles for the pharmaceutical industry and the tools that can be used to reduce patient risk and ensure quality throughout a product’s lifecycle.

After this course learners will be able to recognize fda’s guidance on risk management and the potential uses and benefits for our industry as a whole.