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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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December 06, 2012 |
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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
January 7, 2013 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This course is designed for professionals in the pharmaceutical and medical device industries and those involved with clinical research within these areas. It will be especially beneficial to:
• IT Managers
• System Developers
• System users who need to insure compliance
• Regulatory/QA Managers and Directors
• Managers of automated laboratories, automated
manufacturing systems and automated clinical
testing/analysis systems
• Managers of computerized medical devices Description
This course will be available On Demand: January 8, 2013
21CFR Part 11 has been in the forefront of professionals in the Pharmaceutical and Medical Device Industries for 15 years. Everyone wants to know “what is different now and what’s next?” Many questions arise about current regulations and Part 11’s impact in today’s world.
This 90 minute accredited online training will respond to pressing questions such as:
• Has the US FDA changed its enforcement policy?
• How does Risk assessment impact ERES?
• Do European regulations mirror Part 11?
• What do companies need to do to comply?
• How do we address the new technologies with Part 11-
Cloud, Smart Phones, and Hot -Spots? Etc.?
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Philip E. Sax, Vice President and Chief Regulatory Officer, Medcomp Inc
Philip E. Sax is Vice President and Chief Regulatory Officer for Medcomp Inc, an international Medical Device Firm. Mr. Sax is a pioneer in Part 11 enforcement and training. He has BA from Rutgers University and an MGA form the Wharton School, University of Pennsylvania.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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