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 Speaker Profile

Mark Roberts
Founder, Roberts Consulting & Engineering

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.

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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 principles and standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization.

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Design, Planning and Conducting Effective Audits

Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement.

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