Comprehensive Product Quality System to Achieve FDA Compliance

Topics:
Healthcare Products,
Pharmeceuticals
Tags:
Compliance,
FDA,
Federal Government,
Government,
PRTM,
Quality System
Source:
PRTM

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Overview: A leading international medical device and pharmaceutical company needed to redefine and redeploy their entire quality system in response to the results of an FDA inspection. PRTM led the overall quality system redesign and implementation effort. It created seven internal teams to address each of seven components of the quality system: management control, corrective and preventive actions, design control, document and data control material control, production and process control, and facilities and equipment control. As a result, the client company passed the follow-up FDA inspection, receiving rave reviews that accompanied its implementation.

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