Page 1

Live Webinar


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


Register Now

(for one participant)

Instructor Profile:


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

Click here to register for this webinar

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

Suggest a Topic

More Webinars

Your Necessity is our Priority

Who Will Benefit: l

RA Directors, Managers and Staff


QA Directors, Managers and Staff Internal Audit Staff R&D Directors, Managers and Staff

l l

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

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

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...