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.
Interactive dashboards & analytics in Excel
Copilot and HR: An Introduction for HR Professionals
4-Hour Virtual Seminar on Bootcamp on Excel
Leading Across Generations: 5 Challenges & 10 Strategies to…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Fair Lending in 2025: New Regulations, Examinations and Enf…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Using Emotional Intelligence to Elevate Your Leadership
ChatGPT & HR: How HR Recruiting Professionals Can Leverage …
FDA Trends in Compliance and Enforcement in Computer System…
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
How to Write a Successful Job Hazard Analysis
How to Write Right for Better Business Communication
How to Prepare For and Host a FDA Inspection and Respond to…
Public Speaking: Overcoming The Fear of Public Speaking
From Good to Great: The Secrets to an Optimized LinkedIn Pr…
Workplace Investigations 101: How to Conduct your Investiga…
Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
Transforming Anger And Conflict Into Collaborative Problem …
Navigating Alcohol and Drug Addiction Protections Under the…
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Transforming HR with AI: Unlocking Excellence and Innovation
Creating Employee Handbooks that Protect You and Support th…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Transform Data into Insights: A Beginners Guide to Excel Pi…
Mindful Communication:The Key to Meaningful Conversations i…
FDA Proposes Framework to Advance Credibility of AI Models
50+ new Excel features so far this decade
FMLA Compliance in 2025: A Comprehensive Guide & Strategies…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Hiring and Retaining Employees in this Crazy Economy
Harassment, Bullying, Gossip, Confrontational and Disruptiv…