Foolproof Investigations: A Proven Approach for Root Cause Analysis in a Regulated Environment

November 15, 2019
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cGMP and ISO 13485 Integrated Quality Management System
cGMP and ISO 13485 Integrated Quality Management System

The Food and Drug Administration (FDA) has established and maintains Part 820- Quality System Regulation (Q...

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Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview
Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview

Examine how obtaining ISO 13485 certification can open doors to untapped domestic and international busines...