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:
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.
Note to Editors: Photographs from previous training classes and interviews with EduQuest principals, including Martin Browning, are available upon request.Further Information: Martin L. Heavner301firstname.lastname@example.orgThis press release was issued through eReleases(R). For more information, visit eReleases Press Release Distribution at http://www.ereleases.com.
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