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.
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.
1. Introduction to ICH Q9(R1)
2. Key concepts and definitions
3. The risk management process
4. Risk management in the pharmaceutical industry
5. Quality risk management methods and tools
Quality Assurance/Quality Control Professionals:
Manufacturing and Operations Professionals:
Research and Development Professionals:
Regulatory Affairs Professionals:
Pharmacovigilance and Drug Safety Professionals:
Risk Management Professionals:
Cross-Functional Team Members:
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.
1. Introduction to ICH Q9(R1)
2. Key concepts and definitions
3. The risk management process
4. Risk management in the pharmaceutical industry
5. Quality risk management methods and tools
Quality Assurance/Quality Control Professionals:
Manufacturing and Operations Professionals:
Research and Development Professionals:
Regulatory Affairs Professionals:
Pharmacovigilance and Drug Safety Professionals:
Risk Management Professionals:
Cross-Functional Team Members:
Meredith Crabtree
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.
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