Former FDA Inspectors Train Medical Device, Pharmaceutical Companies How to Comply with New FDA Expectations for Quality Systems
WASHINGTON, April 5, 2010 — EduQuest has trained hundreds of FDA inspectors; now it trains thousands of those getting inspected.
A global team of FDA compliance experts, EduQuest (http://www.EduQuest.net) is presenting a series of training courses for quality managers and regulatory specialists September 13-17, 2010, at the Hotel DuPont in Wilmington, Delaware (near I-95, Amtrak rail lines, and the Philadelphia airport).
Course topics include:
- FDA Auditing of Computerized Systems and Part 11 (3 days)
- Introduction to Risk Management for FDA Compliance (1/2-day)
- Process Risk Management Explained (1 1/2-days)
- Dangerous Documents: Avoiding Landmines in Your Emails and FDA Records (1/2-day)
- Effective and Compliant Corrective and Preventive Action (CAPA) Systems (1 1/2-days)
Each 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 plus the resource realities faced by regulated industry.
During 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 lead course developer is Martin Browning, president 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.
Students can attend the entire week of training classes or select individual courses. Tuition for the full week of training is $3,980, with discounts available for teams of two or more attending from the same company. Courses also are available for on-demand delivery for companies who prefer to have EduQuest come to their facilities.
Course details are available by visiting http://EduQuest.net/current%20courses.htm or by calling +1 (301) 874-6031. By email, contact Email. Twitter users can follow EduQuest news and updates at http://www.Twitter.com/EduQuest_FDA.
Contact: Martin Heavner, EduQuest
Telephone: +1 (301) 874-6031
Email Address: Email
# # #