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Live Webinar

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Validating Radiation Sterilization for Medical Device Industries

Date & Time: Tuesday, August 02, 2011

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Mark Roberts

Location: Online

Price : $245.00

 

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Instructor Profile:

Overview:

Mark Roberts Mark Roberts Founder, Roberts Consulting & Engineering

Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization. Validation is based on the international standard ISO 11137-1:2006 and ISO 11137-2:2006. In this one hour seminar you will obtain a basic understanding of the principles, core requirements of the ISO standard as well as related standards and guidance. We will define  how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness.

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

Introduction Terminology / Definitions Radiation characterization / effectiveness Process Equipment Product and Material Issues Process Definition Validation IQ/OQ/PQ Documentation, review and approval of validation Routine Monitoring Product Release Maintenance of process effectiveness

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Mark Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the Western US for TÃœV SÃœD Product Service. He is an accredited lead auditor and notified body auditor. He still performs audits for notified bodies on a contract basis. He has 30 years of experience in the medical device industry. Prior to joining TÃœV he was with Becton Dickinson in their corporate offices as manager of quality systems. He also held various positions in RA/QA, sterility and engineering for Baxter Healthcare. He is a member of AAMI and ASQC Biomedical. Publications include portions of the ASQC Biomedical Quality Auditor Handbook. He has also been an expert witness on quality systems and sterility for the FDA. ...more

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Validating Radiation Sterilization for Medical Device Industries  

Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same pr...