fda audits on devices
Post on 26-May-2015
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Virgilio Vinas, MD, MPH, PhDCEARA, LLC
4 Major Subsystems1. ManagementControls
2. Design Controls
3. Corrective andPreventive Actions
4. Production andProcess Controls
Linked To 3 Other Subsystems
5. Materials Control
6.Facility & Equip. Controls
7. Records/Documents/Change /Controls
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