Ensuring Safe and Effective Pharmaceutical Products: A Comprehensive Guide to ICH Q9 (R1) Quality Risk Management in the Pharmaceutical Industry

ICH Q9 sets out a systematic, proactive way to manage risks to product quality, patient safety and data integrity, with risk management built into the pharmaceutical quality system across the product life cycle. This 90-minute ICH Q9(R1) quality risk management training focuses on the revised guideline.

You'll learn about the International Council for Harmonisation and the purpose of Q9(R1), then work through key concepts: risk, risk management and the principles of quality risk management. The session follows the five steps of the process, from risk identification and evaluation to control, communication and review.

You'll also see how risk management applies in pharmaceutical manufacturing, drug development and post-marketing activities, along with common QRM methods, tools and example applications.

• Explain the role of ICH and the purpose of ICH Q9(R1)
• Define key terms in risk and quality risk management
• Follow the five steps of the risk management process
• Apply risk management in manufacturing, drug development and post-marketing activities
• Describe common quality risk management methods and tools
• Identify potential applications of quality risk management, including by regulators

1. Introduction to ICH Q9(R1)

• A brief overview of ICH and its purpose
• Introduction to ICH Q9 and why it matters

2. Key concepts and definitions

• Understanding risk and risk management
• Principles of quality risk management
• Risk assessment, control, communication and review

3. The risk management process

• Risk identification
• Risk evaluation
• Risk control
• Risk communication
• Risk review

4. Risk management in the pharmaceutical industry

• Applying ICH Q9 in pharmaceutical manufacturing
• Risk management in drug development
• Risk management in post-marketing activities

5. Quality risk management methods and tools

• Overview of QRM methods and tools
• Potential applications of quality risk management

Applying quality risk management well supports regulatory compliance, stronger quality systems, better decisions, cross-functional collaboration and continuous improvement. This session gives you a foundation in ICH Q9(R1) that you can use in your own role to improve product quality and patient safety.

It suits QA/QC, manufacturing and operations, R&D, regulatory affairs, pharmacovigilance and drug safety, and risk management professionals, plus project managers and cross-functional team members.

Quality Assurance/Quality Control Professionals:

•     Quality Assurance Managers
•     Quality Control Analysts
•     Compliance Officers
•     Regulatory Affairs Specialists

Manufacturing and Operations Professionals:

•     Manufacturing Managers
•     Process Engineers
•     Validation Specialists
•     Production Supervisors

Research and Development Professionals:

•     R&D Scientists
•     Formulation Scientists
•     Product Development Managers

Regulatory Affairs Professionals:

•     Regulatory Affairs Managers
•     Regulatory Compliance Specialists
•     Regulatory Affairs Associates

Pharmacovigilance and Drug Safety Professionals:

•     Pharmacovigilance Managers
•     Drug Safety Specialists
•     Medical Affairs Professionals

Risk Management Professionals:

•     Risk Management Specialists
•     Risk Assessment Analysts
•     Risk Control Officers

Cross-Functional Team Members:

•     Project Managers
•     Cross-Functional Team Members involved in risk assessment and control
•     Quality and Compliance Team Members

Meredith Crabtree has over 25 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical devices, Cosmetics, Supplements, and Animal Health manufacturing and distribution. Meredith works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree, and Recall support. She also performs regulatory assessments and Quality training. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.