April 18, 2006 — SALT LAKE CITY, Utah — Many medical device firms receive Form 483 citations from the FDA because of issues related to quality audits, corrective and preventive actions, employee training records, documentation control, etc.
White Paper: FDA Medical Device Investigator Offers Insights on Inspection
In this question-and-answer paper, MasterControl interviews a medical device specialist with the FDA’s Office of Regulatory Affairs (ORA), who has been inspecting domestic and international medical device companies for the past 12 years. Among other things, the investigator talks about:
–Twelve most common problems of medical device firms pertaining to quality audit.
–Things that FDA investigators look for in terms of CAPA.
–Things that FDA investigators look for in terms of training control.
–How medical device companies can apply “risk-based” approach in quality management.
–What medical device firms should do to prepare for an FDA inspection.
MasterControl Inc. has been at the forefront of providing innovative quality management software solutions since 1993. Over 400 companies worldwide use the MasterControl(tm) solution to consistently meet FDA regulations, ISO standards, and other regulatory requirements. In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. For more information or additional white papers, visit www.mastercontrol.com or call 800-825-9117.