Implementation of the ICH Q9 Guideline on Quality Risk Management

In this Quality Risk Management training develop and implement a policy for a Quality Risk Management Program and determine how to select the direct-impact systems and processes to apply your policy - formal QRM.

The Q9 Guideline will also represent a critical system component of the Quality Systems to be defined on the upcoming ICH Q10 Guideline for Quality Systems that has already been approved for development by the Steering Committee of the ICH. Quality Risk Management must be implemented by developing a general policy and the specific QRM plans for each aspect/area to have their risk analyzed. Formal risk management is not necessary for all risks - only for the more critical/higher impact on product quality.The course will include instructions on how to:

• Develop and implement a policy for a Quality Risk Management Program
• Determine how to select the direct-impact systems and processes to apply your policy - formal QRM

Areas Covered in the seminar::

• History and Background of the ICH Efforts on Risk management
• Scope, Definitions and Basic Principles of Risk Management
• Application of the General Process Requirements for Risk management: Risk Assessment, Risk Control, Risk Communication and Risk Review
• Requirements for a 'formal' risk management - Where/How to apply a formal QRM process?
• Specific applications and Case Studies

Who Will Benefit:

This webinar will provide valuable information for personnel in the following areas:

• Validations
• Manufacturing
• Quality Control/Assurance
• Engineering - Facility and Process
• Research and Development
• Materials Management