Eighth Annual FDA Inspections Summit
Product Details
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 |
Food & Drug Administration |
Par |
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
www.bethesdanorthmarriott.com
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
|
$1,797
|
$1,997
|
Conference Only
|
$1,527
|
$1,697
|
Preconference Workshop
|
$537
|
$597
|
LiveStreaming
|
$1,297
|
$1,497
|
Send Your Team for Maximum Benefit
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 |