FDA/ ICH Guideline Q9 (R1) on Quality Risk Management
Meredith Crabtree has over 25 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health manufacturing and distribution. 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 trainings. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.
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.
Areas Covered
- 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
- b. Principles of quality risk management
- c. 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
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.
Topic Background
ICH Q9, titled "Quality Risk Management," provides a framework and principles for the implementation of quality risk management in the pharmaceutical industry.
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.
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