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« Friday August 06, 2010 »
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Reducing Ethylene Oxide (EO) Sterilization costs while maintaining regulatory compliance
Start: 08/06/2010 10:00 am
End: 08/06/2010 11:00 am

In this Ethylene Oxide (EO) Sterilization training learn how to evaluate your sterilization process for cost reduction, and will learn how to implement such changes without jeopardizing product safety and regulatory compliance.
Why Should You Attend:
Many medical device manufacturer companies are not taking the 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 believes that changes to the sterilization process are too complex or risky.
The application of vanguard sterilization technologies will allow you to reduce sterilization costs with programs such as : reducing or eliminating preconditioning, reducing or eliminating aeration, BI elimination, EO gas consumption reduction and chamber utilization maximization. In this seminar you will acquire the knowledge to evaluate your sterilization process for cost reduction, and will learn how to implement such changes without jeopardizing product safety and regulatory compliance. Analyzing the microbiological and EO residues 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.

Note: Use this Promo Code(101902) to avail Discount of 10% on LIVE Purchase.

How to conduct a software risk assessment that is meaningful
Start: 08/06/2010 10:00 am
End: 08/06/2010 11:00 am

Get detailed understanding of how to perform risk assessment as part of 10 step risk based approach to CSV.
Why Should You Attend:
Learn how to perform risk assessment as part of the 10-step risk-based approach to computer system validation. Minimize project time using fill-in-the-blank templates. Ensure compliance with QA, FDA, and clients. What makes this session unique are the real life examples that make application of the techniques understandable in the context of any validation project.
Areas Covered in the Seminar :

  • How to use the risk-based approach to reduce validation time and lower costs.
  • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
  • Reduce testing by writing test cases that trace to elements of risk management.
  • Avoid 483s and Warning Letters.
  • Interactive real life examples.
  • How to identify risk and establish mitigations.
  • Determine risk in a process to reduce the testing effort.

Note: Use this Promo Code(101902) to avail Discount of 10% on LIVE Purchase.

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