Navigation Links
Former FDA Inspectors Train Medical Device, Pharmaceutical Companies How to Comply with Latest FDA Expectations for Validation and Part 11
Date:10/29/2010

WASHINGTON, Oct. 29 /PRNewswire/ -- EduQuest has trained hundreds of FDA inspectors; now it trains thousands of those being inspected by the Agency.

A global team of FDA compliance experts, EduQuest is presenting the "FDA Auditing of Computerized Systems and Part 11" training course for quality managers and regulatory specialists December 7-9, 2010, at the Hotel DuPont in Wilmington, Delaware (near I-95, Amtrak rail lines, and the Philadelphia airport). Course topics include:

  • Which validation deliverables the FDA expects and what they should contain
  • Why 50 percent of compliance dollars and resources are wasted on ineffective or inadequate validation
  • Top validation errors cited in FDA enforcement actions
  • Proactive steps to avoid CSV and Part 11 Form 483s and warning letters
  • Part 11 rules for electronic records and signatures
  • Ensuring audit trails and safe, secure data access and transfer
  • Evaluating software vendor compliance claims
  • Current status of Part 11 - revisions, rewrite or abandonment?
  • How to prepare for the FDA inspector - using a simulated inspection with real-world scenarios

  • The course is taught by instructors with experience on both sides of the fence as FDA inspectors and as compliance managers for industry. As a result, attendees receive practical guidance from those who understand the expectations of FDA officials as well as the resource realities faced by regulated industry.

    Over the past 15 years, EduQuest has provided training for FDA's Office of Regulatory Affairs (ORA), the lead office for all of FDA's field activities (including inspections and recalls) and for Health Canada inspectors. The course chairman is Martin Browning, president and co-founder of EduQuest and the former vice chair of FDA's Electronic Record and Signature Work Group, where he helped to write the original Part 11 rules.

    Tuition for the three days of training is $2,795, with discounts available for teams of five or more attending from the same company. The class also is available for on-demand, on-site delivery for companies who prefer to have EduQuest come to their facilities.

    Course details are available by visiting http://www.eduquest.net/csv.htm or by calling +1 (301) 874-6031. By email, contact: Info@EduQuest.net.

    Note to Editors: Photographs from previous training classes and interviews with EduQuest principals, including Martin Browning, are available upon request.Further Information: Martin L. Heavner301-874-6031martinheavner@eduquest.netThis press release was issued through eReleases(R).  For more information, visit eReleases Press Release Distribution at http://www.ereleases.com.


    '/>"/>
    SOURCE EduQuest
    Copyright©2010 PR Newswire.
    All rights reserved

    Related biology technology :

    1. Heiner Dreismann, Ph.D., Former President of Roche Molecular Systems, Joins the HistoRx Board of Directors
    2. Regenicin Names Former U.S. Marine Corp Operations Officer, Christopher Hadsall, Chief Operating Officer
    3. Dismissal of Lawsuit by Former Officer Affirmed by Appellate Court
    4. Former Fujifilm Medical Systems USA Executive John J. Weber Agrees to Join Regenicin™ as a Member of Its Board of Directors and Interim CFO
    5. UPDATE: Appeal of Lawsuit by Former Chief Executive Officer- Reinstated; and Sanctions Order Vacated
    6. Appeal of Lawsuit by Former Chief Executive Officer- Reinstated; and Sanctions Order Vacated
    7. Axial Exchange Recruits Karen Evans, Former Fed CIO, to Advisory Board
    8. Appeal of Lawsuit by Former Officer Dismissed; Request for Sanctions Granted
    9. Former French Prime Minister Jean-Pierre Raffarin Visits Sundia
    10. Waukesha Electric partners with SuperPower and UH to build fault current limiting superconducting transformer for Dept. of Energy
    11. Former Congressman Dick Gephardt Brings National Spotlight to Rhode Island with Best and Brightest Forum on Medical Innovation
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:4/28/2016)... The report "Cryocooler Market by ... (Technical Support, Product Repairs & Refurbishment, Preventive Maintenance, and ... 2022", published by MarketsandMarkets, the global market is expected ... a CAGR of 7.29% between 2016 and 2022. ... Figures spread through 159 Pages and in-depth TOC on ...
    (Date:4/28/2016)... ... April 28, 2016 , ... ... Connecticut's innovative, growing companies, today announced the launch of VentureClash , a ... companies. , “VentureClash looks to attract the best early-stage companies here ...
    (Date:4/28/2016)... ... 28, 2016 , ... As part of an ongoing global ... expanding its LATAM network and logistics capabilities. Enhancements have been made to ... trial projects. , The expansion will provide unmatched clinical trial logistics services for ...
    (Date:4/27/2016)... ... ... Cambridge Semantics, the leading provider of Smart Data analytic and ... named to The Silicon Review’s “20 Fastest Growing Big Data Companies of 2016.” ... needs of end users facing some of the most complex data challenges in the ...
    Breaking Biology Technology:
    (Date:3/3/2016)... DE SOTO, Kansas , March 3, ... Plus® to offer Oncimmune,s Early CDT®-Lung, a blood ... detection of lung cancer Early CDT®-Lung test ... individuals. --> Early CDT®-Lung test to its ... --> Oncimmune, a leader in early cancer detection, ...
    (Date:3/2/2016)... 2016 http://www.researchandmarkets.com/research/cmt3hk/global_biometrics ) ... "Global Biometrics as a Service Market 2016-2020" ... --> http://www.researchandmarkets.com/research/cmt3hk/global_biometrics ) has announced the ... a Service Market 2016-2020" report to ... and Markets ( http://www.researchandmarkets.com/research/cmt3hk/global_biometrics ) has announced ...
    (Date:3/1/2016)... March 1, 2016  (RSAC Booth #3041) – True ... whopping $118 billion is lost to false positives, where ... inaccurate fraud detection. At the RSA Conference 2016, NuData ... companies handle authentication by devaluing the data fraudsters have ... --> --> ...
    Breaking Biology News(10 mins):