Medical Devices 2012 - Application of CAPA in (Device) Sterilization ? For the Non-Expert
Date2012-01-20
Deadline2012-01-20
VenuePalo Alto, USA - United States
KeywordsMedical Device Sterilization; Application of CAPA in Sterilization; EO Sterilization; Radiation Sterilization; Sterilization basics; corrective action; CAPA; sterilization process; sterilization assurance; sterilization deficiencies
Topics/Call fo Papers
This webinar will review the typical non-conformances experienced in the (Medical Device) sterilization process and the course of action that should be taken by the manufacturer or contract sterilizer.
Why Should You Attend:
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.
Areas Covered in the Seminar:
- Basic critical control points of EO and Radiation Sterilization.
- Review of typical nonconformities.
- Review of actions that should be taken by the sterilization processor.
- What should you expect from your contract sterilizer as it relates to CAPA issued by sterilizer or you the manufacturer.
Why Should You Attend:
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.
Areas Covered in the Seminar:
- Basic critical control points of EO and Radiation Sterilization.
- Review of typical nonconformities.
- Review of actions that should be taken by the sterilization processor.
- What should you expect from your contract sterilizer as it relates to CAPA issued by sterilizer or you the manufacturer.
Other CFPs
Last modified: 2011-12-08 20:51:41