FDA/ICH Guideline Q9 (R1) on Quality Risk Management

This comprehensive training session on the International Council for Harmonization (ICH) Q9 guideline, with a special focus on the revised version, ICH Q9(R1). Gain a deep understanding of the fundamental principles, concepts, and practical application of the risk management approach as outlined in this esteemed guideline. Discover how these principles directly impact the pharmaceutical industry and learn about the various applications and cutting-edge tools employed for effective Quality Risk Management. Benefit from real-world examples illustrating the application of these tools.

By participating in this training program centered around ICH Q9(R1), you will acquire the essential knowledge and skills needed to successfully implement quality risk management principles. Achieve regulatory compliance, enhance your quality systems, reduce costs, make informed decisions, foster cross-functional collaboration, and cultivate a culture of continuous improvement within the pharmaceutical sector.

Why You Should Attend:

Upon completion of this training, you will possess a solid foundation in ICH Q9(R1) and its guiding principles. Empowered with this expertise, you will be able to seamlessly integrate risk management practices into your respective roles within the pharmaceutical industry. Contribute to elevated product quality, heightened patient safety, and unwavering regulatory compliance, ultimately driving excellence in every facet of your organization.

Areas Covered in the Session :

• 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

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Risk Management Professionals
• Pharmacovigilance and Drug Safety Professionals
• Project Managers involved in Risk Assessment and control

Course Director: MEREDITH CRABTREE

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.