2-day In-person Seminar: Medical Device Sterilization: Corrective & Preventive Action (FDA GXP Compliance -)
Venue: Hyatt Regency Irvine
|Event Date/Time: Jun 14, 2012||End Date/Time: Jun 15, 2012|
This will be followed by process validation and what paperwork is required to provide â€˜documented evidenceâ€™ ; and finally what are typical deficiencies encountered in the EO process. Next a detailed explanation of Radiation Sterilization will be given. Specific to Radiation Sterilization is the required sterilization dose, which will be covered in depth â€“ how to determine sterilization dose and how to maintain the validated dose. Process validation will be covered as well as the typical deficiencies encountered in Radiation Sterilization and Validation. Critical and non-critical deficiencies will be covered and when this should trigger a CAPA. Finally contract sterilization will be reviewed with the specifics of how to deal with CAPA when you are not directly responsible for sterilization.