This 90-minute webinar aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application of the risk management approach outlined in the guideline, and how it relates to the pharmaceutical industry. This session will discuss some potential applications and tools used in the industry for Quality Risk Management.  Additionally, a few examples of how to apply these applications will be reviewed.

Course Objectives: 

1) Understand the purpose and significance of ICH Q9(R1): Participants will gain knowledge about the International Council for Harmonisation (ICH) and its role in regulatory harmonization. They will understand the purpose and importance of ICH Q9(R1) as a guideline for quality risk management in the pharmaceutical industry.

2) Comprehend key concepts and definitions: Participants will grasp the fundamental concepts and definitions related to risk and risk management. They will learn about the principles of quality risk management and become familiar with terms such as risk assessment, risk control, risk communication, and risk review.

3) Summary of Recent Revisions: Participants will understand the most recent revisions (R1) to the guidelines.  They will gain an understanding of the rationale behind the changes.

4) Gain knowledge of the risk management process: Participants will learn about the step-by-step risk management process outlined in ICH Q9(R1). They will understand the five key steps involved in risk management, including Hazard identification, risk evaluation, risk control, risk communication, and risk review.

5) Recognize the integration of risk management in the pharmaceutical industry: Participants will understand how risk management principles and practices are applied in the pharmaceutical industry. 

6) Overview of the Quality Risk Management Methods and Tools:  Participants will be provided with a general summary of the methods and tools that are best practices in quality risk management.

Course Outline:

1) Introduction to ICH (Q9) R1 Regulations 

a. Brief overview of ICH and its purpose 

b. Introduction to ICH Q9 and its significance

c. Explanation of the recent revisions of the guidelines

2) Key Concepts and Definitions 

a. Understanding risk and risk management 

b. Principles of quality risk management 

c. Risk assessment, control, communication, and review

3) Risk Management Process 

4) Overview of the risk management process:

a. Health identification 

b. Risk evaluation 

c. Risk control

d. Risk communication

e. Risk review

5) Quality Risk Management Methods and Tools

6)  Integration of Risk Management in the Pharmaceutical Industry 

a. Application of ICH Q9 in pharmaceutical manufacturing

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

• Quality Assurance Managers

• Quality Control Managers/Supervisors

• Process and Design Engineering Personnel

• Process Automation Staff

• Manufacturing Operations Staff

• Validation Specialists

• Utility Operations Staff

• Regulatory Affairs Personnel

• Compliance Officers and Legal Professionals

• Social Media Managers and Content Creators

• Communication and Public Relations Professionals,