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Speaker Profile
TROY FUGATE

Troy Fugate is the Vice President of Compliance Insight, bringing over three decades of experience helping pharmaceutical, biotech, and medical device companies navigate the complex world of FDA compliance. Known for his leadership in GMP workforce development and inspection strategy, Troy is a trusted advisor to companies preparing for — or recovering from — FDA scrutiny. His firm, Compliance Insight, has a track record of helping organizations strengthen their systems, empower their teams, and emerge stronger after every inspection.


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$199.00
What the FDA 483 Really Means — And How to Respond Like a Pro

 Troy Fugate
 July 09 2025
 01 : 00 PM EST    
 60 Minutes
What the FDA 483 Really Means — And How to Respond Like a Pro

An FDA Form 483 isn’t just a list of observations — it’s a statement about how the agency views your quality system.And the moment you receive one, the clock starts ticking.The days and weeks that follow are critical. How you respond to a 483 says more about your organization than the inspection itself. The content, structure, and tone of your response tell the FDA whether you’re serious about fixing the is..

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$200.00
How to Prepare for an FDA Inspection

 Troy Fugate
 Recorded Webinar
 60 Minutes
How to Prepare for an FDA Inspection

FDA inspections are not just routine regulatory encounters — they are high-stakes, high-visibility events that can impact your organization's reputation, product pipeline, and commercial success. Whether you’re a pharmaceutical manufacturer, a biotech startup, or a medical device company, your inspection readiness reflects not just your documentation, but your culture, your leadership, and your operational ..

Showing 1 to 2 of 2 (1 Pages)