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Quality Risk Management Overview for Pharma and Biopharma, ICH Q9/ISO 14971
Friday, November 9, 2012 from 9:00 AM to 10:30 AM (PST)
Palo Alto, CA
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:
- 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
Date: November 09, 2012
Time: 09:00 AM-10:30 AM PDT
Cost: $249 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.