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 control.

In this webinar, Troy Fugate, a nationally recognized compliance leader with over 30 years of industry experience, will walk you through a pragmatic, field-tested approach to inspection preparedness. Troy has supported companies before, during, and after some of the industry’s most intense regulatory audits — and in this session, he’ll share the exact strategies that have helped organizations pass inspections with confidence, not chaos.

Why This Matters Now

Inspections are returning to full force, and the FDA is increasingly focused on data integrity, risk-based systems, and the culture of quality, not just SOPs in a binder. Let’s be clear: your systems need to be more than compliant — they need to be inspection-ready at all times.

The companies that fare well in these audits aren’t the ones who scramble to “clean up” in the weeks leading up to an inspection. They’re the ones who’ve embedded compliance into the fabric of daily operations — and who prepare their people to respond with clarity, competence, and credibility.

Learning Objectives

This isn’t a theoretical session. You’ll leave with practical tools you can apply immediately, including:

How to build a proactive inspection strategy

• 90-day, 30-day, and 7-day action plans
• How to identify and close systemic gaps before the FDA does
• The difference between “looking ready” and being ready
  

What FDA investigators are truly evaluating

• The key questions they ask — and what they’re listening for
• How they assess leadership engagement and data integrity
• Common triggers that escalate from 483s to Warning Letters
  

How to run your site during an active inspection

• Assigning the right roles: front room, back room, runners, and scribes
• Managing difficult questions with honesty and control
• Real-world examples of what to say — and what not to
  

Top mistakes that lead to disastrous outcomes

• Misaligned messaging across departments
• Incomplete or outdated procedures and training records
• Systems that work on paper but fail in practice
  

Areas Covered

• How to build a proactive inspection strategy
   -  90-day, 30-day, and 7-day action plans
   -  How to identify and close systemic gaps before the FDA does
   -  The difference between “looking ready” and being ready
• What FDA investigators are truly evaluating
   - The key questions they ask — and what they’re listening for
   -  How they assess leadership engagement and data integrity
   - Common triggers that escalate from 483s to Warning Letters
• How to run your site during an active inspection
   -  Assigning the right roles: front room, back room, runners, and scribes
   -  Managing difficult questions with honesty and control
   -  Real-world examples of what to say — and what not to
• Top mistakes that lead to disastrous outcomes
   -  Misaligned messaging across departments
   -  Incomplete or outdated procedures and training records
   -  Systems that work on paper but fail in practice
  

Who Should Attend

This webinar is built for professionals who carry the weight of compliance on their shoulders, including:

• Directors and VPs of Quality, Compliance, and Regulatory Affairs
• Quality Assurance Managers and Specialists
• Manufacturing and Operations Leaders
• Site Heads and Frontline Supervisors
• Compliance Officers and Audit Readiness Teams
  

If you’ve ever asked yourself, “Are we really ready for the FDA?”, this session will give you the clarity and confidence to answer with conviction.

Why Should You Attend

FDA inspections aren’t just another item on your compliance checklist — they’re pivotal moments that can define the reputation, credibility, and operational future of your organization.

The question isn’t if you’ll be inspected. It’s when — and more importantly, how ready will you be?

That’s why we’re hosting a high-impact, no-fluff webinar:

“Preparing for an FDA Inspection: How to Lead, Defend, and Win.”

Led by Troy Fugate, Vice President of Compliance Insight and a 30+ year veteran of pharmaceutical and medical device compliance, this session will give you real-world strategies — not theoretical guidance — on how to prepare your team, your systems, and yourself for FDA scrutiny.

What You’ll Walk Away With:

• A practical framework for inspection readiness – What to do 90 days out, 30 days out, and Day One.
• What FDA investigators are actually looking for – and how to respond with clarity and confidence.
• Top mistakes companies make – And how to make sure you don’t become the next 483 headline.
• How to build a team that performs under pressure – Because your response is only as strong as your people.
  

This webinar is for:

• Quality and compliance leaders who want to sharpen their team’s inspection posture
• Operations and manufacturing managers who support regulatory inspections
• Anyone who's been through a tough inspection and knows the stakes
  

If your response to “Are we ready for the FDA?” is anything short of confident, this session is for you.

Topic Background

The US FDA can visit your site for any number of reasons:  PAI, PLI, Annual Inspection, For-Cause Inspection.