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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
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.
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.
Meredith Crabtree has over 25 years’ experience in regulated industries ranging from Pharma, Medical Device, Biologics, Laboratory testing, Cosmetics, and Supplements. She has worked in both manufacturing and distribution as well as Human Health and Animal Health. Meredith currently 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.