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Home / Online GXP courses / Quality Assurance / Risk Analysis Model for Management of Quality Risk
Successful completion provides learners with a dated, traceable and downloadable certificate for the course : Risk Analysis Model for Management of Quality Risk
Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.
The pharmaceutical industry relies on limits that have been established through research, to evaluate the quality of products, raw materials, and by-products at every phase of the manufacturing process. Risk analysis is a necessary component of (QRM) as it unearths hidden issues in the manufacturing process.
This course introduces you to the concept of 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.
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.
Introduction
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)
Conclusion
Glossary
Quiz
$95.00
$95.00
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