Eighth Annual FDA Inspections Summit

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Mark your calendar for the Eighth Annual FDA Inspections Summit taking place Oct. 23-25, 2013 in Bethesda, MD.

Testimonials From Satisfied FDA Inspections Summit Attendees:

“Excellent conference. Thank you for putting it together!”
          – Stephanie Hendrickson, Life Sciences Quality and Compliance, Accenture

“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

“Very informative and worthwhile of my time.  I’m thankful this forum exists.  This is my third year of attending this Summit and I look forward to seeing Lori Lawless present every year.”
          – Mark Gerhardt, Site Quality Assurance Leader, Noxell

“I am thankful that this forum exists. Hearing from FDA experts, former and current is a plus. Very informative and worthwhile of my time.”
          – Harjeen Arora, Principal Specialist GCP, Sanofi Aventis

“Great speakers.”
          – James Miller, Senior Quality Systems Analyst, Roche

“Variety of speakers and topics”
          – Johanna Stamates, Executive Director Regulatory Support and Quality Assurance University of Miami

2012 Speakers Included:

Featured Speakers:

  • Steve Silverman, Director, Office of Compliance, CDRH, FDA
  • Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
  • David Glasgow, Director, Division of Domestic Field Investigations, ORA, FDA
  • Ralph Tyler, Partner, Venable LLP; former Chief Counsel of the FDA
  • David Elder, Vice President of Strategic Compliance Services, PAREXEL Consulting

Summit Faculty:

  • Barbara Immel, President, Immel Resources (Summit Chairperson)
  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding, former Deputy Associate Commissioner, Regulatory Operations and Chief Operating Officer, ORA, FDA
  • Dr. Gilda D’Incerti, CEO, Pharma Quality Europe
  • Deborah Geyman, Senior Manager Corporate Quality Audit, St. Jude Medical
  • Dr. Stephen Goldman, Managing Member, Stephen A. Goldman Consulting Services, formerly FDA’s first Medical Director of MedWatch
  • Steven Grossman, President, HPS Group, Deputy Executive Director, Alliance for a Stronger FDA, Publisher, FDA Matters: The Grossman FDA Report, former Deputy Assistant Secretary for Health, HHS
  • Connie Hoy, Vice President, RA/QA, Cutera
  • Julie Larsen, Director, Inspection Readiness Services, BioTeknica
  • Dr. Jeanne Mattern, Director, QHS Regulatory Compliance Office, Cleveland Clinic
  • Dan O'Leary, President, Ombu Enterprises
  • Matt Quirk, Manager, Clinical QA, St. Jude Medical
  • Kenneth White, Principal Scientist, Clinical Research and Bioscience Group, Social & Scientific Systems
  • Christina Arnt, Post Market Surveillance Manager, St. Jude Medical
  • Elaine Messa, Executive Vice President of the Medical Device Practice, Becker & Associates Consulting, Inc.
  • Michael Bloh, Independent Safety and Pharmacovigilance Consultant
  • Frederick Branding, Principal Attorney, Olson Frank Weeda
  • Scott Cunningham, Partner, Covington & Burling
  • Darshan Kulkarni, Principal Attorney, The Kulkarni Law Firm
  • Cathy Burgess, Partner, Alston & Bird
  • JeanMarie Markham, CEO, Clinogix

2013 Agenda:

Please check back for the agenda updates.

View Past Event Agendas and Brochures:

Abbott Laboratories
Actavis Pharmaceuticals
Aderans Research Institute
Alliance Healthcare Information
Amphastar Pharmaceuticals
Arthrex, Inc.
Ascom Inc.
AxSource Consulting Inc.
Bausch + Lomb
Baxa Corporation
Baxter Healthcare
Benevue Medical
Berlin Heart Gmbh
BioPharm, Inc.
Biosante Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Boston Analytical
Boston Scientific
Bristol-Myers Squibb
Chemwerth Inc.
Church & Dwight
Compliance & Management Assoc.
Corium International
CSL Behring
Cubist Pharmaceuticatis
Deka Research and Development
Department of Health & Human Services
DPT Laboratories
DynPort Vaccine Company LLC
Eli Lilly
Endo Pharmaceuticals
Eurofins Lancaster Laboratories
Fisher & Paykel Healthcare

Food & Drug Administration
Fort Wayne Metals
Fresenius Medical Care
Fujirebio Diagnostics, Inc.
GE Healthcare
Gedeon Richter
Gilead Sciences, Inc
Globus Medical. Inc
Golden State Medical Supply
Greer Laboratories
Hi Tech Pharmacal
Hogan Lovells US LLP
i3 InVentiv Health
ICON Medical Imaging
International Labs
Johnson & Johnson
Kao USA Inc.
Kaplan EduNeering
Lantheus Medical Imaging
Lifecell Corporation
Lifecore Biomedical
LNK International
McNeil Consumer Healthcare
Medline Industries
Medtronic Inc.
Millenium Pharmaceuticals
MIM Software Inc.
MPI Research
Nephron Pharmaceuticals Corp.
New Mountain Capital
Norwich Pharmaceuticals, Inc.
Novo Nordisk
NxStage Medical Inc.
Ohio Medical
Onyx Pharmaceuticals
Optimer Pharmaceuticals

Patton Boggs
Perkin Elmer Inc.
Photothera, Inc .
Playtex Manufacturing
Portola Pharmaceuticals
Posey Company
Prentke Romich Company
Procter & Gamble
QMS Consulting
Resmed Ltd.
RJ Reynolds
Roche Molecular Sytems Inc.
Sage Products
Sandoz International
Sanofi Aventis
Sanofi Pasteur
Sarah Cannon Research Institute
Seton Medical Center
Siemens Healthcare Diagnostics
Sigma, LLC
Smith & Nephew
Sorin Group
Southeastern Technology
Spectrum Pharmaceuitcals
St. Jude Medical
Stiefel, a GSK Company
Taro Pharmaceuticals Inc.
Technical Resources
Terumo Medical
Teva Pharmaceuticals
UCB, Inc.
UL EduNeering
University of Miami
W.O.M. World of Medicine AG
Walter Reed Army Institute of Research

2013 Sponsors:

Silver Sponsor

Bronze Sponsor


For 2013 exhibit options and sponsorship packages contact Jim Desborough, Director, Business Development at (703) 538-7647 or jdesborough@fdanews.com

Special Thanks to Our 2012 Sponsors:


2013 Venue:

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
North Bethesda, MD 20852
Toll free: (800) 859-8003 • Tel: +1 (301) 822-9200
Room rate: $209 plus 13% tax
Reservation cut-off: Oct. 1, 2013

Register for 2013:

Early Bird Fee
Until Sept. 20, 2013
Regular Fee
After Sept. 20, 2013
Complete Summit
Conference Only
Preconference Workshop

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2-4 attendees – 10%
7-9 attendees – 20%
5-6 attendees – 15%
10+ attendees – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600
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Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Cancellations and Substitutions

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.