Risk Based Approach to Software Quality Validation Webinar
Time: 10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Richard L. Chamberlain
This webinar will discuss developing procedures for including risk management in software quality validation; risk management standard operating procedure development and maintenance; standard operating procedures for step-by-step activities; measure quality and demonstrate compliance to risk management requirements and produce quality validation records.
During the last several years, the FDA has increased its emphasis on risk management. At the same time new technologies are changing the way many things are done in the Pharmaceutical, Medical Device, and other industries. This has increased the importance and use of risk management procedures for much of the work that is done today.
Why Should you Attend:
This course will put you in a position to better include risk in decisions regarding what activities are required to better demonstrate compliance.
Objectives of the Presentation:
- How to organize the risk management processes and procedures
- How to develop SOPs that include risk management
- The development of training modules to support the SOPs
- The production of "risk products" that provide quality records and fit with Computer Validation
- How to apply change control to risk management
- Who are and what are the roles of the various Stakeholders?