Do your Microsoft Excel spreadsheets pass FDA muster? Can they meet strict 21 CFR Part 11 standards? Would you like to learn a defined approach that can make your task simple and straightforward saving you both time and money? Order this hands-on learning experience led by a trusted spreadsheet validation expert. Training is critical for anyone in the drug or device industry who oversees or uses spreadsheets for data collection, data processing or data reporting.
It's every drug- and devicemaker’s worst nightmare — inspectors coming through your front door with the power to shut you down. They're highly trained … ruthlessly committed to spotting your tiniest flaws … and tough as nails. If only you could question investigators in detail … before an inspection. Maybe you'd learn what you need to do to pass. Would they tell you? The answer is yes.
A review of several corrective and preventive action (CAPA) forms at Aqueduct Medical’s San Francisco facility revealed inadequate CAPA validation and follow-up, a recent Form 483 states. Aqueduct, a maker of masks and vests for use by patients during recovery from facial and cosmetic surgery, opened several CAPAs in 2010 and 2011 to address defective welds but did not document any follow-up with its contract manufacturers, the Dec. 7, 2011, form states. The GMP Letter