Risk Management in (FDA) Quality and Manufacturing Areas – Understanding What the Regulators Expect and Working it to your Advan
Submitted by Anonymous on Thu, 09/22/2011 - 01:19
12/15/2011 10:00 am
12/15/2011 10:00 am
America/Chicago
Why Should You Attend:
This webinar will provide valuable information on the value of Risk Management in pharmaceutical, device and biotechnology operations and meeting agency expectations. It includes rationales for the use of the techniques in a variety of scenarios from plant design and construction through operations in the plant such as setting up monitoring, conducting investigations and validation planning and execution. It describes the components of the processes including how to initiate risk management, risk assessment and risk control, implementation and review of remediation and feedback linking into continuous improvement.
Areas Covered in the Seminar:
- Why Risk Management techniques are critical in both development of product and processes and also manufacturing operations and their controls?
- Where these techniques can be used in everyday operations?
- The major elements of the Risk Management process from initiation, through risk assessment and control to implementation, review and communication.
- The methodology for risk identification, quantification and prioritization.
- How Risk Management integrates and become an important element of Continuous improvement and your Quality Management System?
- What the agencies expect from you when you use the techniques?
Webinar Presenters:
Peter Calcott

