Risk Management in a Nutshell
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Who Should Attend
This online training will benefit professionals in the following industries:
Medical Device, Pharmaceutical, Human Tissue, Biotechnology.
In departments such as:
QA/QC/RA, Manufacturing/Operations, Research and Development, Legal
With job functions:
Department managers and supervisors, QA/QC/RA specialists and engineers, Manufacturing and R&D engineers, chemists, scientists, formulators, documentation specialists, auditors, technicians
Description
This course will examine the current industry-regulatory environment and will give you tools for survival; it will
provide a step-by-step guide to the essential requirements of a Risk Management System including setting-up,
operating, and managing the system for today’s FDA regulated industry environment.
Module 1:-
Background-Regulatory Requirements
- What is Risk Management, anyway?
- What are the Four Steps of the Risk Management Process?
- Step One: What do you mean I need a Risk Management Plan?
Step Two: Risk Assessment. Let’s illustrate the Concepts
Module 2:-
Step Two: Risk Analysis. A simple example
- Step Two: Risk Analysis. How do I Perform and Document It?
- Step Two: Risk Evaluation. So does it Matter?
Module 3:-
Step Three: Risk Control. How do I mitigate an identified risk?
- Step Three: So did it help?
- Step Three: And I need to document it?
- Step Four: When does this all end?