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    CLINICAL TRIAL MANAGEMENT SYSTEMS ARE NOT MEDICAL 2012 - FDA Guidance Regarding Software Validation for Clinical Trial Management Systems - Webinar By GlobalCompliancePanel

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    Website http://bit.ly/OB0CVt | Want to Edit it Edit Freely

    Category online Training,Clinical Management Systems,CTMS ,General Principles of Software ValidationQuality Management System

    Deadline: October 30, 2012 | Date: October 30, 2012

    Venue/Country: Wilmington, U.S.A

    Updated: 2012-09-27 19:55:05 (GMT+9)

    Call For Papers - CFP

    Overview: Clinical trial management systems are not medical devices yet the software used to collect clinical trial information should be validated and some have suggested the software validation steps used for medical device development may be appropriate.

    This talk will review two current FDA guidance documents on this topic including "Computerized Systems Used in Clinical Investigations" which is clearly applicable to CTMS and "General Principles of Software Validation" which is more directly applicable to software within a medical device. Key features of a good CTMS software validation process will be presented and a review of the required Quality Management System Standard Operating System documents will be provided.

    Why should you attend: The available FDA guidance documents do not clearly describe how to validate clinical trial management systems (CTMS). CTMS developers, users at sites and vendor/site auditors are left to interpret the clinical trial regulations and FDA guidance documents. Two guidance documents will be reviewed in this webinar: "Computerized Systems Used in Clinical Investigations" which is clearly applicable to CTMS and "General Principles of Software Validation" which is more directly applicable to software within a medical device; however, many auditors point to this guidance and may attempt to require rigorous software validation principals which may not be the "least burdensome" path for CTMS development.

    Areas Covered in the Session:

    Key 'software validation' approaches related to CTMS will be presented

    The FDA guidance for industry "Computerized systems used in Clinical Investigations" will be discussed in detail

    Details appplicable to CTMS development will be detailed as described in the FDA guidance “General Principles of Software Validation”

    Key CTMS software validation steps will be discussed

    Who Will Benefit:

    Presidents and CEOs of CTMS providers

    CTMS developers, testers auditors

    Site Managers responsible for CTMS selection

    Directors of Clinical and Regulatory Affairs

    Managers of Quality Affairs

    Clinical Research Coordinators & Associates

    Clinical Project Managers, Research Nurses, Scientists and Others

    Joy Frestedt, PhD, CCTI, RAC, FRAPS. Dr. Frestedt is the President and CEO of Frestedt Incorporated, a novel virtual Contract Research Organization network of over 50 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical and medical device industries especially running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and the development of quality systems to compete globally. She has held key positions including vice president of scientific, regulatory and clinical affairs at BridgePoint Medical and Humanetics Corporation as well as key management positions with Johnson and Johnson’s Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZenca Pharmaceuticals and Orphan Medical. Dr. Frestedt holds a B.A. in biology from Knox College and a Ph.D. in pathobiology from the University of Minnesota Medical School and she is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, American Society of Clinical Research Professionals and she is a Fellow of the Regulatory Affairs Professionals Society. Dr. Frestedt was named one of the “100 Most Inspiring People in the Life Sciences Industry (by PharmaVOICE, 2011) and one of the top 25 “Industry Leaders/ Women in Business Award (by the Minneapolis/St. Paul Business Journal, 2011).

    Webinar By GlobalCompliancePanel

    Price List:

    Live : $245.00

    Corporate live : $495.00

    Recorded : $295.00

    Phone: 800-447-9407

    Fax: 302-288-6884

    webinarsatglobalcompliancepanel.com

    http://www.globalcompliancepanel.com

    1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801


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