Failure Mode and Effects Analysis for Design Improvement and Design Control (Medical Devices)
Venue: Online Event
|Event Date/Time: Jul 21, 2011||End Date/Time: Jul 21, 2011|
Risk analysis is now required by law (GMP). Identification of device design problems prior to distribution eliminates costs associated with warranties, product recalls, and product validation.
FMEA can reveal missing requirements, missing functions, and point out component and manufacturing problems well before process validation. These in turn reduce life cycle costs and reduce the time to market. Design FMEA serves as a central document in the Design Control process Similarly the Process FMEA serves as the central document in the Process Validation qualification.
Attend this webinar to learn how you can design medical devices that enhance reliability, durability, safety, and serviceability. This seminar covers both: the Design FMEA, and the Process FMEA.
Areas Covered in the Seminar:
FMEA methodology-the right way
- FMECA process overview for Design Control
- Avoiding wrong practices
- Best practices
Design FMEA Procedure
- Defining failure mode
- Identifying failure modes
- Identifying failure mechanisms
- Assessing frequency of failure
- Assessing the severity of failure
- Assessing the detection rating
NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.