ICH Q9 quality risk management in practice
Amid today's ever-evolving regulatory environment, adherence is vital. Our white paper delves into the significance of nurturing a quality culture – embedding quality in all endeavors – as the linchpin for achieving and upholding compliance.
What you'll discover:
- The importance of ICH Q9 quality risk management (QRM): Understand how QRM safeguards drug integrity and ensures patient safety, supporting compliance with stringent regulatory standards.
- Core principles and framework of ICH Q9 QRM: Learn about the systematic process of assessing, controlling, communicating and reviewing risks to maintain high-quality standards.
- QRM in pharmaceutical operations: Explore integrating QRM into quality management systems (QMS) and using tools like FMEA and FTA to enhance drug development, manufacturing and supply chain management.
- Overcoming challenges and leveraging technology: Discover strategies for successful QRM implementation, including leadership commitment, cross-functional collaboration and digital tools for proactive risk management.
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