Pre-Recorded CD Webinar
Approximately 90 minutes in length, Self Examination and Answer Key Included
Who Will Benefit
This CD Webinar is a must-attend for professionals in FDA regulated companies, including:
- Compliance officers
- Plant engineers
- Laboratory personnel
- Operations and Manufacturing
- General/corporate counsel
A new administration and a newly empowered FDA are going to tighten the reins on facility 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 as world-recognized compliance experts we 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 an FDA Inspection Gone Wrong delivers:
- The 10 things you must NEVER do during an FDA 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 details contained within the company’s actual EIRs, Form 483s and warning letters.
Then we take 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 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.
Order On-Line to Own This CD Webinar: $195.00