ComplianceOnline

How to reduce EO residuals in medical devices

Instructor: Marisel Ortiz
Product ID: 701798
  • Duration: 60 Mins

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2011

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Ethylene Oxide Sterilization Residuals regulation based webinar will provide a practical approach to fulfill requirements of the new ISO EO residual limits revised regulation.

Why Should You Attend:
The revision to ISO 10993-7:2008 Biological Evaluation of Medical Devices—Part 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 it’s 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.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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