Ninth Annual FDA Inspections Summit

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2014 Highlights

  • 4 panels featuring current and former FDA officials, including:
    • New for 2014 Understanding FDA’s Quality Metrics Initiative – what’s the latest on the quality initiative and how can you get prepared for what’s coming?
    • New for 2014The latest on the FDA’s re-organization of the inspectional corps and how could it impact your daily operations and your upcoming inspection
    • A day in the life of an investigator -- how inspectors prepare and approach assigned inspections
    • Discussing inspectional protocols – how should you treat investigators when they are in your facility
  • Best practices in FDA 483 and warning letter management and recovery
  • 2 pre-conference workshops; focusing on drugs and devices — “something for everyone”
  • And more…

The FDA Inspections Summit — now in its ninth year — has fast become the “go-to” event for regulatory, compliance and quality assurance professionals and the one place to discover the tools and techniques to improve your inspectional readiness.

Join us for this rare opportunity to interact with top officials from CDER, CDRH, CBER, the Office of Regulatory Affairs and other outstanding industry leaders to discuss debate and uncover the latest priorities, expectations and best practices.

NO OTHER conference brings together so many of the industry’s inspectional professionals. This is your one chance to come to the nation’s capital and interact with the top minds in the FDA arena. As you network with these senior-level professionals, you’ll discuss the latest developments from the FDA and Congress and how you need to position your firm to assure successful inspections.


“The summit was very informative. There were powerful insights about
FDA that I took away from the summit. It will be helpful in setting strategy for my organization.”

– Raghu Jainapur, Director of Quality Assurance, Roche

“Excellent conference. Thank you for putting it together!”

– Stephanie Hendrickson, Life Sciences Quality and Compliance, Accenture


Highlights from 2013

Kim Trautman: Update on IMDRF and MDSAP
Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH, FDA

A Day in the Life of an FDA Investigator

  • Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
  • Rachel Harrington, CSO, Drug Specialist, ORA, FDA, Baltimore District
  • Erin McFiren, Consumer Safety Officer, ORA, FDA, Baltimore District
  • Tim Wells, President, QualityHub; former Team Leader for the QSIT Project, CDRH, FDA
  • Larry Spears, Director, Deloitte & Touche LLP, former Deputy Director for Regulatory Affairs at CDRH, FDA
  • Rhona Shanker, Director, Regulatory Consulting, Z & B Enterprises, Inc., former FDA, CDRH, ODE Expert Regulatory Reviewer
  • Elaine Messa, President, Medical Devices, NSF Health Sciences; former Director of the Los Angeles District, FDA

Marie McDonald: Warning Letter Recovery Strategies
Marie McDonald, Senior Director, Quality & Compliance Consulting, Quintiles