Risk Analysis Model for Management of Quality Risk

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.

Curriculum

Introduction

• 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

Conclusion

Glossary

Quiz