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"Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and ‘running’ requests back and forth from the conference room. This software tool has been tested during my simulated FDA mock inspections and it serves to overall stream-line the inspection process. As a former FDA investigator, I fully endorse this software tool and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line!"
- Jeff Yuen, MPH, MBA Former Commander, FDA |
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