Risk Analysis Model for Management of Quality Risk

Risk Analysis Model for Management of Quality Risk13

Duration :


1 hour(s)

Skill level:




Final exam:


Certificate of Completion:


CEU / CPD Accreditation:



Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

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.






  • Background and Scope
  • Quality Risk Management (QRM)
  • Aim of the Quality Risk Management (QRM) to the Pharmaceutical Industry
  • Principles of Quality Risk Management


Lesson 1: Purpose of Quality Risk Management (QRM)


  • Quality Target Product Profile (QTPP)
  • Finished Pharmaceutical Product (FPP)
  • Critical Process Parameters (CPPs)
  • Critical Quality Attributes (CQAs)


Lesson 2: Quality of Risk Management Process


  • Personnel Involved in QRM
  • Product and Process Knowledge
  • Risk Assessment
  • Maintenance of Risk Assessment Records
  • Risk Control
  • Risk Review
  • Verification of Quality Risk Management Process and Techniques
  • Communication and Documentation of Risks


Lesson 3: Pharmaceutical Applications of QRM


  • Responsibilities
  • QRM Application During Product Development
  • Use of QRM in Commercial Manufacturing
  • Integrating QRM with Critical Components of the Quality System
  • Application of QRM in Product Manufacture


Lesson 4: QRM Considerations for Medicines Regulatory Authorities


  • QRM Application to Inspection Strategy


Lesson 5: Risk Management Tools


Lesson 6: Project Risk Analysis and Management (PRAM)


  • Qualitative Risk Analysis
  • Quantitative Risk Analysis
  • Benefits of PRAM








Dr. Masaab Bashir
Dr. Massab Bashir holds a Ph.D. in Microbiology and Immunology. Dr. Bashir leads a medical and research writing team of qualified doctors. Massab and his team have over five years of research writing experience in the medical, biotech, and pharmaceutical fields. To date, Dr. Bashir and his team have successfully completed more than 500 projects


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