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The pharmaceutical industry relies on limits that have been predetermined through research to evaluate the quality of products, raw materials, and by-products at every phase of the manufacturing process. This course introduces you to the concept of Quality Risk Management (QRM) which must be applied all through the manufacturing process, even at the level of raw material suppliers to ensure that the final pharmaceutical products and devices are safe and effective for patients’ use. Risk analysis is a necessary component of QRM as it unearths hidden issues in the manufacturing process.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Purpose of Quality Risk Management (QRM)
Lesson 2: Quality of Risk Management Process
Lesson 3: Pharmaceutical Applications of QRM
Lesson 4: QRM Considerations for Medicines Regulatory Authorities
Lesson 5: Risk Management Tools
Lesson 6: Project Risk Analysis and Management (PRAM)