FDAnews announces Seventh Annual FDA Inspections Summit

FALLS CHURCH, Va., Aug. 16, 2012 /PRNewswire-iReach/ -- Seventh Annual FDA Inspections Summit
**Presented by  FDAnews**
Sept. 19-21, 2012Bethesda, MD

(Photo: http://photos.prnewswire.com/prnh/20120816/CG58970)

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.

Distinguished FDA Speakers:

  • Steve Silverman, Director, Office of Compliance, CDRH, FDA
  • Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District

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
  • Ron Johnson, President, Becker & Associates Consulting, Inc., former Director of Compliance, CDRH, 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
  • Katlyn Tissue, Quality Supervisor, GENICON
  • Kenneth White, Principal Scientist, Clinical Research and Bioscience Group, Social & Scientific Systems
  • Christina Arnt, Post Market Surveillance Manager, St. Jude Medical

Who Should Attend:

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

Seventh Annual FDA Inspections Summit
**Presented by  FDAnews**
Sept. 19-21, 2012Bethesda, MD

Early Bird (Must register by Aug. 21, 2012): $1,797 per attendee 
Regular Tuition (Aug. 22-Sept. 21, 2012): $1,997 per attendee

4 Easy Ways to Register
Online: www.fdanews.com/FDAInspections
By phone: 888-838-5578 or 703-538-7600
Fax:    703-538-7676
Mail to: FDAnews
           300 N Washington St
           Ste 200   
           Falls Church VA USA 22046-3431

Media Contact: Jeff Grizzel, FDAnews, 703-538-7668, jgrizzel@fdanews.com

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