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Former FDA Inspectors Train Medical Device, Pharmaceutical Companies How to Prepare for FDA Inspections of Their Quality Systems
Date:8/16/2012

WASHINGTON, Aug. 16, 2012 /PRNewswire/ -- EduQuest has trained hundreds of FDA inspectors; now it's training thousands of those preparing for inspections.

A global team of FDA inspection experts, EduQuest is presenting a series of training courses for quality managers and regulatory specialists September 24-28, 2012, at the Hilton Garden Inn in Frederick, Maryland (near Baltimore and Washington, DC, just off Interstates 70 and 270).

Course topics include:

- FDA Auditing of Computerized Systems and Part 11/Annex 11, including a mock FDA inspection (3 days)

- Quality Risk Management for FDA/ICHQ9 Compliance (1/2-day)

- The CAPA Confidence Clinic: Effective Corrective and Preventive Action (CAPA) Systems, Failure Investigations, and Complaint Management (1 1/2-days)

Each course is taught by instructors with personal experience conducting FDA inspections and being quality system expert advisors for industry. As a result, attendees receive practical guidance from those who understand the expectations of FDA inspectors plus the resource realities faced by regulated industry.

Over the past 15 years, EduQuest has trained FDA's Office of Regulatory Affairs (ORA), the lead office for all of FDA's field activities (including inspections and recalls) and Health Canada inspectors.

The lead instructor is Martin Browning, president of EduQuest and the former vice chair of the FDA Electronic Record and Signature Work Group, where he helped to write the original Part 11 rules for quality data security and integrity.

Students can attend the entire week of training classes or select individual courses. T
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