Seventh Annual FDA Inspections Summit

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Each year, the FDA makes adjustments to its inspection processes and policies. This year is no exception. Recent important changes include:

  • If you think you can easily stop the FDA from taking pictures of your facility during an inspection, think again.  The FDA now advises its inspectors to not ask for permission but take their cameras into facilities and take pictures as they see fit.  If a firm complains, the new policy is for the inspector to contact the firm’s legal counsel and advise the district management immediately.
  • A new user fee may be assessed if FDA conducts a reinspection to evaluate corrective actions that were classified Official Action Indicated (OAI) and determined to be material.  This fee may also be assessed for not complying with a recall order issued by FDA under section 423 or 412(f).
  • FDA investigators are actively data mining your records during inspections.  As nearly all inspectors are using laptops and tablets during their inspections, many are asking for electronic copies of complaint or AER data and taking it back to their hotel rooms each evening to dissect the data and be prepared to ask additional questions the next morning.  Providing old or inaccurate data can quickly lead to problems.

These changes and many more are to be discussed at the Seventh Annual FDA Inspections Summit.  Year after year, the crème de la crème of the industry make it their business to attend this conference and tap into the cumulative knowledge of an accomplished group of top officials from CDER, CDRH, CBER, the Office of Regulatory Affairs (and more).

Register today to hear about breaking news directly from prominent FDA officials. That's why you can't afford NOT to attend the Seventh Annual FDA Inspections Summit on Sept. 19-21 in Bethesda, MD.

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

Register Today

Live on-line viewing of the entire 7th Annual FDA Inspections Summit

Can’t make it to the 7th Annual FDA Inspections Summit? Attend the live sessions from your computer. Participate in the live conference from your home or office. Watch the live-streaming video of the presenter and view the presentation materials in real time. Ask questions of the presenters and download handout materials. By registering you will also receive six months’ access to archived session recordings after the conference ends. Registration is quick, and accessing the live sessions is as simple as clicking your mouse.

2011 Video Highlights:

Highlight: Five Things the FDA's ORA Plans to Focus On in 2012
Conference: Sixth Annual FDA Inspections Summit, October 5, 2011, Bethesda, MD
Speaker: Roberta Wagner, Deputy Associate Commissioner for Field Operations, ORA, FDA
Presentation: 4,000 Employees Strong - What Are ORA’s Goals for 2011-2012? 
Time: 2 minutes, 20 seconds

Highlight: How Does the FDA Decide Which Firms It Chooses to Inspect?
Conference: Sixth Annual FDA Inspections Summit, October 5, 2011, Bethesda, MD
Speaker: Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
Presentation: An FDA Investigator’s Perspective in Assuring a Firm's Top Seven Subsystems Are in Compliance and Linked Together
Time: 1 minute, 40 seconds

Sampling of Companies that Attended in 2011:

Abbott Laboratories
Actavis Pharmaceuticals
Aderans Research Institute
Alliance Healthcare Information
Amphastar Pharmaceuticals
AxSource Consulting
Benevue Medical
Biosante Pharmaceuticals
Boehringer Ingelheim
Boston Analytical
Boston Scientific
Bristol-Myers Squibb
Corium International
DPT Laboratories
DynPort Vaccine
Eli Lilly

Endo Pharmaceuticals
Fisher & Paykel Healthcare
Fort Wayne Metals
GE Healthcare
Gedeon Richter
Gilead Sciences
Globus Medical
Golden State Medical Supply
Greer Laboratories
Hogan Lovells US
i3 InVentiv Health
LNK International
MPI Research
Nephron Pharmaceuticals
Norwich Pharmaceuticals
Novo Nordisk

Ohio Medical
Onyx Pharmaceuticals
Optimer Pharmaceuticals
Playtex Products
Posey Company
Prentke Romich
Procter & Gamble
Sage Products
Sanofi Aventis
Sarah Cannon Research Institute
Southeastern Technology
St. Jude Medical
Terumo Cardiovascular
University of Miami
W.O.M. World of Medicine
Walter Reed Army Institute of Research

  • Executive Management
  • Regulatory Affairs
  • Quality Assurance/Quality Control
  • Legal and Compliance Officers
  • Clinical Research Directors
  • Consultants/Service Providers

2012 Sponsor:


For 2012 exhibit options and sponsorship packages contact Colette McMullen, Director, Business Development at (703) 538-7642 or

2012 Venue:

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
Bethesda, MD 20852
Toll free: (800) 859-8003 • Tel: +1 (301) 822-9200

Register for 2012:

Regular Fee
Complete Summit
Conference Only
Preconference Workshop
Livestreaming Full Conference
(including 24/7 access to the content for six months after the event)

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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.