Quality Risk Management

Risk management has a strong role as a precautionary tool for the regulation of pharmaceutical and biopharmaceutical products. Preventing healthcare hazards from happening in the first place requires approaches to minimize risk to patient safety and health proactively, rather than reactively. This is where Quality Risk Management (QRM) comes in.

In the following lessons:

• We will discuss Quality Risk Management principles and their practical application in the pharmaceutical industry, which will aid in the development and production of high-quality medicinal goods.
• We will explain Quality Risk Management (QRM) models and processes that can be applied to various aspects of pharmaceutical quality.
• Finally, we’ve included a short quiz at the end of the course to test your knowledge and understanding of the course.

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

• Why is quality risk management needed
• Formal and Informal Risk Management Processes

Lesson 1: Principles of Quality Risk Management

• Primay principles
• Secondary principles

Lesson 2: Quality Risk Management Process

• Risk assessment
• Risk control
• Risk communication
• Risk review

Lesson 3: Managing Risks – Quality Risk Management Methodology

Lesson 4: Application of Quality Risk Management in the Pharmaceutical Industry

• Commercial Manufacturing
• Product development

Lesson 5: Role of Quality Risk Management in Regulatory Affairs

• QRM in Compliance Inspections
• QRM in Inspection Planning & Risk Assessment
• QRM in Dossier Review

Conclusion

Glossary

Quiz