Reusable Device Cleaning, Disinfection, and Sterilization Validations

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Reusable Device Cleaning, Disinfection, and Sterilization Validations: Overview and Key Design Considerations for Device Engineers

Date & Time: Wednesday, February 22, 2012

10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

Instructor: Rudy Pina

Location: Online

Price : $245.00

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(for one participant)

Instructor Profile:

Why you should attend:

Rudy Pina Lab Director, Dynatec Scientific Labs

To assist you in the identification of key factors during the development of your protocol. you will be guided on how to identify key factors in the protocol design process. Key factors such as selection of chemical agents specifically biocidal agents and or biostatic agent(s). Identify testing that will be required to evaluate these proposed agents Biocompatibility issues, such as should you test for cytotoxicity, tolerable contact limit (TCL) as stated in ISO 10993-7. If you require sterilization of your reusable should packaging and penetration issues be addressed. What will be the required sterility specifications for your product. Sterility assurance issues will be discussed. You will be able to write and review medical device reprocessing protocols and assists in the revision process, in order to eliminate or minimize process interruptions.

Areas Covered in the Session: l l l l l l

Key points regarding protocol development A summary of standards Key tests to be familiar with Expected results Packaging issues Labeling issues

Rudy Pina has over 30 years of experience in The Medical Device Industry. He has worked for American Hospital Supply, Baxter Healthcare. Rudy is President of Dynatec Scientific Laboratories Inc. Rudy is a member of the Association for the Advancement of Medical Instrumentation (AAMI) Sterilization Working Group. Member of FDA/Industry Coolition - Dallas District Office Member of NAFTA Trilateral Negotiations - Medical Technology Sector. ...more

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Engineering Quality Validation Microbiology Process/ Scientist Manufacturing Regulatory Affairs

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

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