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FDA - ICH Guideline Q9 R1 on Quality Risk Management
Introduction to ICH (Q9) R1 Regulations
- Brief overview of ICH and its purpose
- Introduction to ICH Q9 and its significance
Key Concepts and Definitions
- Understanding risk and risk management
- Principles of quality risk management
- Risk assessment, control, communication, and review
Risk Management Process
Overview of the risk management process
- Risk identification
- Risk evaluation
- Risk control
- Risk communication
- Risk review
Integration of Risk Management in the Pharmaceutical Industry
- Application of ICH Q9 in pharmaceutical manufacturing
- Risk management in drug development
- Risk management in post-marketing activities
Quality Risk Management Methods and Tools
Potential Applications for Quality Risk Management
Overview of the webinar
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.
Who should attend?
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
Why should you attend?
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.
Faculty - Miss.Meredith Crabtree
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.