June 18-19, 2014
Marriott Bethesda North Hotel & Conference Center
This Event Has Been Cancelled.
For now, this conference is not being rescheduled,
but we will let you know if this changes.
Click here to see other upcoming conferences and webinars by FDAnews.
New in 2014 — One-of-a-kind workshop teaches proven tips and tricks for training your auditors to spot even the slightest violations — before the FDA does.
In two action-packed days, you'll learn what FDA investigators use to evaluate your sites. This interactive workshop will teach you how to develop risk-based CQA processes and compliance readiness.
You'll benefit from the first-hand knowledge and experience of workshop leader and expert Michelle Sceppa, a 25-year quality assurance and regulatory compliance veteran in both the pharmaceutical and medical device industries.
Some of the most common Form 483 citations issued to clinical sites include:
Any one of these could derail your project, costing you millions in lost revenue. On June 18-19 in Bethesda, MD, auditing veteran Michelle Sceppa walks you step by step through such details as:
Throughout the workshop, you'll also participate in invaluable Interactive Exercises that will make you feel like you're engaged in an actual inspection, giving you priceless hands-on experience that will serve you well for years to come.
Identify the elements of and compose a central laboratory audit SOP … learn the 5 Key Tools for CQA Auditors: Preparation, Performance, Interviewing, Writing and Post-Assessment — and how to confidently employ them … and much, much more.
Finally, you'll walk away after two days with valuable tools you'll be able to put to use immediately:
Clear your calendar NOW for Risk-Based Clinical Quality Assurance: Train Your Auditors Like the FDA Does on June 18-19, 2014, in Bethesda, MD.