Quality Risk Management Overview for Pharma and Biopharma, ICH Q9/ISO 14971 November 8, 2012

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.

Learning Objective:

Understand the principles of Quality Risk Management to:

Identify
Analyze
Evaluate
Control
Reduce
Accept
Communicate and
Review risks throughout product life cycle

Areas Covered in the Seminar:

Quality Risk Management Overview

Understanding Risk
Application of ICH Q9
Definitions and Concepts
Risk Assessment
Risk Control
Risk Communication
Risk Review
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.

Production
Engineering
Quality control
Product development
Marketing and
Regulatory affairs

Official Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702422?channel=yahooevent