The purpose of ICH Q9 is to ensure a systematic and proactive approach to managing risks that may affect product quality, patient safety, and data integrity. It recognizes that risk management should be an integral part of the pharmaceutical quality system and be applied throughout the lifecycle of a product, from development to post-marketing activities.
Overall, ICH Q9(R1) plays a crucial role in promoting a proactive and systematic approach to risk management in the pharmaceutical industry. It aligns with regulatory expectations and industry best practices, ensuring the delivery of safe and effective pharmaceutical products to patients worldwide.
The training session 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.
Attending this training on ICH Q9 (R1) can provide individuals with the necessary knowledge and skills to implement quality risk management principles effectively. This can lead to regulatory compliance, improved quality systems, cost savings, enhanced decision-making, cross-functional collaboration, and a culture of continuous improvement within the pharmaceutical industry.
After this training, participants will be equipped with a foundational understanding of ICH Q9(R1) and its principles. They will be able to apply risk management practices in their respective roles within the pharmaceutical industry, contributing to improved product quality, patient safety, and regulatory compliance.
Introduction to ICH (Q9) R1 Regulations
Key Concepts and Definitions
Risk Management Process
Overview of the risk management process:
Integration of Risk Management in the Pharmaceutical Industry
Quality Risk Management Methods and Tools
Potential Applications for Quality Risk Management
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:
Attending this training on ICH Q9 (R1) can provide individuals with the necessary knowledge and skills to implement quality risk management principles effectively. This can lead to regulatory compliance, improved quality systems, cost savings, enhanced decision-making, cross-functional collaboration, and a culture of continuous improvement within the pharmaceutical industry.
After this training, participants will be equipped with a foundational understanding of ICH Q9(R1) and its principles. They will be able to apply risk management practices in their respective roles within the pharmaceutical industry, contributing to improved product quality, patient safety, and regulatory compliance.
Introduction to ICH (Q9) R1 Regulations
Key Concepts and Definitions
Risk Management Process
Overview of the risk management process:
Integration of Risk Management in the Pharmaceutical Industry
Quality Risk Management Methods and Tools
Potential Applications for Quality Risk Management
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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