Course offering number:0912-702
Course ID:
2332
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Keys to Risk Management: Implementation, Documentation, Monitoring and Mitigation
In Conjunction with Wiley-Blackwell
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This program will benefit anyone wanting to gain an overview of how to approach risk management in the Pharmaceutical,
Biologics, Medical Device or Human Tissue industries including personnel in:
• Q.A.
• R&D
• Validation
• Manufacturing
• Technical Support
• Audit
• Q.C.
• Documentation Functions
Description
This 90-minute accredited training will focus on the current industry-regulatory environment and will give you tools for survival
and success in developing a Risk management system. It will provide a step-by-step guide to the essential requirements of a
Risk Management System including the basics of implementation, documentation and monitoring, plus guidance for mitigation
once a risk has been identified. Typical problems and risk system failures drawn from actual case studies will also be addressed.
Module 1:
• What is risk management and why should we do it?
• Implementing the basic 4 parts of the system,it's subparts,
and strategies for implementation
• A typical Risk management plan and format
Module 2:
• What is a life cycle approach to the system?
• Documenting the system
• Examples of typical risk analyses from pharmaceuticals,
biologicals, medical devices, and human tissue
Module 3:
• Risk Mitigation: What are steps we can take to address
risks once we have identified them?
• What departments play key roles in
the risk management
system?
• How can we measure the effectiveness of the system?
• What are typical risk system disasters and how can they
be corrected
Question and Answer Session