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HUM-MOLGEN
-> Events
-> Meetings and Conferences |
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February 25, 2010 |
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GlobalCompliancePanel, Online
March 9, 2010
Radiation sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies. Proper understanding of the principles and requirements of the related standards is crucial to proper compliance. In addition, understanding the requirements and integrating them early in the product design can lead to quicker time to market. This seminar will help RA/QA staff understand the basic principles as well as the standards and regulations. This will be useful when reviewing validation plans, performing internal audits and dealing with regulators. It is also beneficial to R&D staff to understand the requirements so they may be incorporated into the design inputs correctly.
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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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 TÜV SÜD 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 TÜV 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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Deadline for Abstracts:
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March 2, 2010
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Registration:
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Tuesday, March 9, 2010
11:00 AM PST | 02:00 PM EST | | | Live live online training only for one participant | | |
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| | | Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) | | |
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E-mail:
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webinars@GlobalCompliancePanel.com
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