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

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.

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

Event Details:

Date:              November 09, 2012

Time:              09:00 AM - 11:00 AM PST

Cost:              $249 per attendee per computer terminal

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