Anatomy of a Medical Device Inspection: From EIRs to 483s to Warning Letters

Held March 18, 2009

A new administration … a newly empowered FDA … are going to tighten the reins on medical device inspections. Now more than ever, you need to know what works and what doesn’t work.

Yes, you can read through any company’s warning letter. They’re publicly available. But world-recognized compliance expert Michael Patrick Barile will take you much further. Through Establishment Inspection Reports (EIRs), 483s and warning letters, you’ll get a rare look at the root causes and inspectional failures committed by one company.

This case study walks you step-by-step through three years in the “inspection life” of a real-world medical device company — allowing you to learn risk-free from someone else’s actual glitches.

Anatomy of a Medical Device Inspection, a 90-minute audio CD/Transcript from FDAnews delivers:

  • The 10 things you must NEVER do during a medical device inspection (and the five you must ALWAYS do)
  • Everyday mistakes that catch an FDA inspector’s eye
  • How these mistakes could have been prevented
  • Steps you can take now to steer clear of similar inspection traps

Plus, you’ll access the company’s actual EIRs, Form 483s and warning letters.

Then Michael takes you one step further, offering specific advice on avoiding sanctions — such as how to: 

  • Even the playing field — tips for interacting with the FDA during any inspection
  • Manage the process with confidence — field-tested tactics to make it smooth and speedy
  • Find (and fix) inspection hotspots hiding in your medical device company right now
  • Act decisively if you’re ever faced with a Form 483 — what to do, what to document

If you wait until your next inspection, it’s too late. So why agonize over the seizures and shutdowns that can ruin your credibility?

Take the first step toward inspection success right now.

This audio CD/Transcript is a must-attend for positions in medical device companies, including:
  • Compliance officers
  • QA/QC
  • Plant engineers
  • Laboratory quality control
  • Operations
  • Manufacturing
  • General/corporate counsel
  • Regulatory/legislative affairs professional
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Michael Patrick Barile, founder and managing partner of Barile and Associates, has more than 25 years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the senior quality assurance position in both start-up and large multinational corporations, specializing in difficult turnaround situations. His depth of experience in both line and corporate management has given Michael a unique and practical hands-on expertise with a wide variety of challenges over a diverse range of product technologies. A recognized expert in risk management, software and process validation, continuous improvement methods and quality systems, he lectures worldwide in seminars and for various trade groups.

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