ComplianceOnline

Reducing Ethylene Oxide (EO) Sterilization Costs While Maintaining Regulatory Compliance

Instructor: Marisel Ortiz
Product ID: 701616
Training Level: Advanced
  • Duration: 60 Min

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

Training CD

$449.00
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: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

In this Ethylene Oxide (EO) Sterilization training, you will learn how to evaluate your sterilization process for cost reduction/process efficiency, and also learn how to implement such changes without jeopardizing product safety and regulatory compliance.

Course "Reducing Ethylene Oxide (EO) Sterilization Costs While Maintaining Regulatory Compliance" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

Many medical device manufacturers are not taking advantage of latest sterilization technologies and knowledge to effectively reduce the sterilization process cost. This is due mainly to: lack of knowledge of latest technologies, fear of getting out of regulatory compliance or belief that changes to the sterilization process are too complex or risky.

In this session, you will acquire the knowledge to evaluate your sterilization process for cost reduction, and learn how to implement such changes without jeopardizing product safety and regulatory compliance. Analyzing the microbiological and EO residual aspects of your cycle with a different approach will result in re-engineering it for cost reduction and avoidance while complying with EN/ISO11135.

Areas Covered in the Seminar:

  • Introduction.
  • Factors Influencing Lethality and Aeration.
  • Finding Opportunities for Cycle Optimization.
    • Negotiate cost reduction
    • Initial Validation Evaluation
      • Microbiological Method
      • Cycle Parameters Evaluation
      • EO residues dissipation curves
      • Product Evaluation
  • Cycle/Process Re-engineering
    • BI Incubation reduction
    • Parametric Release
    • PCD/Packaging/Pallet modification
    • Lethality curve development
    • Aeration modification
  • 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 and VP of manufacturing/ quality
  • Quality or laboratory personnel
  • Product Managers
  • Regulatory Affairs
  • Quality or laboratory personnel

Instructor Profile:

Marisel Ortiz, is the founder and President of Sterilization Expert, a consulting company offering technical consultation services in microbiology and sterilization fields. With over twenty two (+23) years experience in management and the application of vanguard sterilization and microbiology technology in world-wide leader companies such as: Baxter, McGaw, Edwards Lifesciences, Cardinal Health and Teleflex Medical Marisel is now dedicated to share her knowledge and experience with the Industry. She has been recognized to be the sterilization expert driving competitive advantage through innovative solutions thus creating greater value while maintaining full regulatory compliance. Was renowned for uncompromisable ethics and integrity and for always honoring commitments.

Marisel has three Bachelor degrees in Science: Pre-medicine, Industrial Microbiology and Biology. She graduated with Cum Laude honors from the prestigious University of Puerto Rico, Mayaguez campus.

She is founder member of the Industrial Microbiology Society of Puerto Rico University.

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