Medical Device Sterilization: Corrective & Preventive Action - Seminar By ComplianceOnline

Course Description:-

The course will begin with an overview of EO sterilization, explaining which aspects of the process often cause confusion. This will be followed by process validation and what paperwork is required to provide ‘documented evidence’ ; 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 – 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.

Who will Benefit:-

This course will be beneficial to the following personnel in Medical Device Manufacturing and Sterilization facilities:

• QA Personnel
• CAPA Team Members
• SA Personnel
• Quality Engineers
• Operations Managers
• Anyone with direct hands on experience with sterilization & troubleshooting

Instructor :-

Ms. Foster began her medical device career at Sterigenics International in 1989. Throughout her tenure, Ms. Foster has held various quality assurance positions at both the facility and Corporate levels where she served as Sterigenics Vice President of Quality Assurance from 1997 – 2004 and as Vice President SteriPro Labs & Consulting from 2004-2011.

Ms. Welch is a Senior Partner with Center for Risk-based Strategies (CRS), a company focused on improving the bottom line of regulated companies. She has over 20 years of experience in the Medical Device, Pharmaceutical and Diagnostics industry with a primary focus in Quality Improvement and Quality Systems. She held positions of increasing responsibility, both technical and managerial, at Abbott Laboratories, Sybron International, AbTox, and Aksys, Ltd. 

For Registration :- 

http://www.complianceonline.com/ecommerce/control/seminar?product_id=80015SEM&?channel=hummolgen