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
– 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:
- 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
- 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
Please check back for the agenda updates.
View Past Event Agendas and Brochures:
Aderans Research Institute
Alliance Healthcare Information
AxSource Consulting Inc.
Bausch + Lomb
Berlin Heart Gmbh
Boehringer Ingelheim Pharmaceuticals
Church & Dwight
Compliance & Management Assoc.
Deka Research and Development
Department of Health & Human Services
DynPort Vaccine Company LLC
Eurofins Lancaster Laboratories
Fisher & Paykel Healthcare
Food & Drug Administration
Fort Wayne Metals
Fresenius Medical Care
Fujirebio Diagnostics, Inc.
Gilead Sciences, Inc
Globus Medical. Inc
Golden State Medical Supply
Hi Tech Pharmacal
Hogan Lovells US LLP
i3 InVentiv Health
ICON Medical Imaging
Johnson & Johnson
Kao USA Inc.
Lantheus Medical Imaging
McNeil Consumer Healthcare
MIM Software Inc.
Nephron Pharmaceuticals Corp.
New Mountain Capital
Norwich Pharmaceuticals, Inc.
NxStage Medical Inc.
Perkin Elmer Inc.
Photothera, Inc .
Prentke Romich Company
Procter & Gamble
Roche Molecular Sytems Inc.
Sarah Cannon Research Institute
Seton Medical Center
Siemens Healthcare Diagnostics
Smith & Nephew
St. Jude Medical
Stiefel, a GSK Company
Taro Pharmaceuticals Inc.
University of Miami
W.O.M. World of Medicine AG
Walter Reed Army Institute of Research
For 2013 exhibit options and sponsorship packages contact Jim Desborough, Director, Business Development at (703) 538-7647 or firstname.lastname@example.org
Special Thanks to Our 2012 Sponsors:
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
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After Sept. 20, 2013
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