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Key deadlines

Conference starts:

2017-01-19

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Conference Description

Overview:
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

The following subjects will be covered in detail:

Materials Guidances - AAMI TIR # 17, ASTM
Sterilization validation and Bioburden
Shelf Life Test Methods - Accelerated Aging design
Product design
The influences of product assembly (molding, automation, etc.)’
Material selection and post irradiation degradation
Regulatory Guidances - AAMI/ISO 11137, TIR #17
Packaging Design and Materials

Why should you Attend:
"Do it right the first time", choose the most functional and radiation resistant materials for your medical device instead of going through the post launch cycle of product revisions. Also learn the basis for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics. Learn how to "think like a molecule" and plan and design around radiation induced changes in materials qualities (color, odor, brittleness). How to avoid the materials that are "APT" to fail.

Areas Covered in the Session:
Polymers Chemistry - choosing the best polymer candidate
Gamma, E-beam, X-ray sterilization
Accelerated Aging
Product Validation
Sterilization Validation - Establishing the baseline dose

Who Will Benefit:
Medical product design engineers
Sterilization Experts
Quality Management and Engineers
Regulatory Affairs

Speaker Profile:
Karl J Hemmerich has over 35 years of experience in medical device product design, development, manufacturing, and sterilization. He specializes in sterilization method selection and program development with emphasis on component material selection, process development and sterilization process validation.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
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