ComplianceOnline

Radiation Dose Setting - Method 1

Instructor: Joyce Hansen
Product ID: 700119
Training Level: Advanced
  • Duration: 60 Min

recorded version

$249.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
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CD and Ref. material will be shipped within 15 business days

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The steps for conducting Method 1 and identifying typical issues that might arise when conducting the test method.

Description

This presentation is the first of three presentations on the methodologies for the determiniation of the minimum sterilization dose.

The new version of ISO/EN 11137-2:2006 has been approved and will be published mid-year 2006. This standard includes three methods for determination of the minimum sterilization dose. This presentation will review the steps for conducting Method 1 and identifying typical issues that might arise when conducting the test method.

Areas Covered in the seminar:

:
  • Dose setting Method 1 from ISO/EN 11137:2006, "Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose’
  • The basis for the method
  • The procedureal steps for conducting the method
  • Updates based upon new the ISO/EN document
  • Typical issues that might arise

Who Will Benefit:

This webinar will provide valuable assistance to all regulated healthcare manufacturers that are using radiation sterilization to sterilize their products. The employees who will benefit will include individuals in the following areas:

  • Quality Assurance
  • Sterility Assurance
  • Validation
  • Auditors
  • Manufacturing and Operations
  • Research and Development

Instructor Profile:

Ms. Hansen, is currently the President of J.M. Hansen & Associates, Inc. which is a consortium of consultants that specialize in the testing for sterilization and maintenance of sterility. Ms. Hansen has over 26 years of industrial sterilization experience. She most recently held the position of Vice President, Sterility Assurance for Baxter Healthcare and Sterilization Core Competency Champion. She held positions at Sherwood, Davis & Geck as Director, Global Sterility Assurance; and at Becton Dickinson as Manager of Microbiological Services for Corporate Quality Assurance. Ms. Hansen is currently convenor of ISO/TC 198 Working Group 2 on Radiation Sterilization.

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