This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.
Why Should You Attend:
In this 90-minute webinar we will define risk and what constitutes risks primarily per ICH Q9 and reference ISO 14971 where applicable. The presenter will discuss principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.
The overall goal of this course is to raise awareness for Quality Risk Management to improve patient safety and also to prepare organizations for regulatory inspections. The session provides quality assurance professionals with a management perspective to make the right decisions for their organization to balance cost vs. risk.
This training provides participants with the knowledge, tools and confidence to understand and participate in a risk management program in a pharma and biopharma industry and an understanding of the significance of effective communication.
Understand the principles of Quality Risk Management to:
Review risks throughout product life cycle
Areas Covered in the Seminar:
Quality Risk Management Overview
Application of ICH Q9
Definitions and Concepts
Example of Risk Management Methods and Tools
Who Will Benefit:
This training discussion seminar has been designed for quality assurance personnel in Pharmaceutical and Biopharmaceutical Industries.
It also addresses staff from other departments too, in so far as they are subject to EU and FDA GMP compliance.
Added by complianceonlinecom on November 7, 2012