How To Reduce Eo Residuals In Medical Devices

Why Should You Attend:

Why Should You Attend:

The revision to ISO 10993-7:2008 Biological Evaluation of Medical DevicesPart 7: Ethylene Oxide Sterilization Residuals, significantly reduced the amount of residual EO or its by-products allowed to be left on Medical devices. The transition period defined to reach compliance with the new EO residual limits ends on October 2011. The new EO residual limits impose a tremendous challenge as its requires a significant investment of time, effort and capital in middle of a tough economic climate.

This webinar will offer ways to re-evaluate, re-design, or re-engineer your products, test methods and/or sterilization process to find opportunities for the simplest, fastest and most economical solutions to the problem. Additionally this webinar will offer ideas to transform a challenge into a potential opportunity for cost reduction. We will also discuss the practical approach to fulfill the regulation requirements.

Areas Covered in the Seminar:

Introduction.

- Benefits/challenges

- EO residual limits comparison

Factors influencing EO residuals

Product/Process Evaluation

- Initial validation evaluation

- Product /packaging/pallet configuration Evaluation

Process Re-engineering.

- PCD/packaging/pallet modification

- Lethality curve development

- Aeration/Degassing Modification

- Application of assumed transfer reduction factors

References.

Who Will Benefit:

This seminar is designed for professionals with responsibility for validating or making decisions related to the EO sterilization process

- Sterilization/Quality Managers

- Directors or VP

- Quality or laboratory personnel

- Chemists

- Chemistry laboratory Managers

- Validation specialists

Instructor Profile:

Marisel Ortiz, Over 24 years of management experience in the application of vanguard sterilization and microbiology technology. Experienced in: Quality System audits, CAPA, Ethylene Oxide (EO), Gamma Radiation, Steam autoclave, Biocompatibility program, Environmental controls, critical systems and laboratory operations, Cleaning/Disinfection/Sterilization of reusable products including cycle development, validation and routine monitoring processes. Recognized as the sterilization expert driving competitive advantage through innovative solutions that create greater value while maintaining full regulatory compliance. Renowned for uncompromised ethics and integrity. Strong educational background combining industrial microbiology, pre-medicine, and biology. Experience/training in CGMP, QSR, QSIT, ANSI/AAMI/ISO, DoH, EN, and OSHA regulations. Fluent in English and Spanish.

by: ComplianceOnline

POST COMMENT

Medical Device Complaints Handling Strategies Medical College Admission Test Improve Your Look At London Medical And Aesthetic Clinic Tips - Male Enhancement Drug That Really Works Medical Transcription Service Providers Provide Quality Services Sandbag - China Quality Medical Supplies - China Medical Elastic Bandage Medical Treatment Uprising Highly No problem, said Seretide GSK denied the two best-selling drugs have been stopped - GlaxoSmithKline - the pharmaceutical industries UN International Day Against Drugs CR systems allow you to acquire, archive, view and distribute medical images easily and inexpensively Work Uniforms And Medical Uniforms Fit Better When Measured Properly Medical Malpractice Lawyers Bow Draw - Forearm Crutch - Medical Aluminium Crutches