Application of CAPA in (Device) Sterilization â€“ For the Non-Expert (Medical DeviceTraini)
Venue: Online Event
|Event Date/Time: Jan 20, 2012||End Date/Time: Jan 20, 2012|
Most device manufacturers utilize a contract sterilizer for terminal sterilization of their products, e.g., radiation and EO. Non-conformances can occur during the sterilization process and CAPA needs to be issued by the manufacturer or contract sterilizer. For those that are not sterilization experts, a basic knowledge needs to be obtained to determine that the CAPA root cause, action to prevent recurrence, and verification/validation of the CAPA has been performed.
As the world and meaning of CAPA evolves in the device manufacturing environment, further misunderstanding comes about when determining root cause and corrective action for this critical step in the device manufacturing process.
This presentation will help you better understand the sterilization process and how the manufacturer can manage CAPA as it relates to the sterilization process. This webinar will review typical non-conformances experienced in the sterilization process and the course of action that should be taken by the sterilization processor.