FDA uses MedCon 2012 conference to share key insights

MedCon begins May 1st!

Top FDA speakers and Industry experts will cover the following agenda topics at MedCon 2012 (May 1-4, 2012). Will you be there?

For complete details, review our 2 ½ day agenda.

MedCon 2012 Topics:

Industry Keynote Address – The Big Picture: How the Balance between regulatory safety and innovation promotion will play out over the next decade

Speaker: Kem Hawkins


EU Regulations and Impact (standards, clinical requirements, harmonization and comparison of current state to previous two years)

Speaker: Gert Bos


FDA Keynote Address: CDRH Medical Device Innovation Initiative

Speaker: Dr. Jeffrey Shuren


510(k) – ODE Perspective

Speaker: Christy Foreman


New International Medical Devices Regulators Forum (IMDRF) and FDA Bilateral Initiatives

Speaker: Kim Trautman


The Purchasing Control Subsystem – Requirements and Implementation

Speakers: Kim Trautman, Steve Niedelman


Draft 510(k) Guidance – Deciding When to Submit a 510(k) for a Change or Modification

Speaker: Phil Phillips, Dennis Hahn, Christy Foreman


ISO 13485 Voluntary Audit Report Submission Pilot Program

Speaker: Kim Trautman

FDA 483s and Regulatory Action. Response Workshop

Speaker: Steve Silverman, Steve Niedelman

Global Recalls

Speaker: Gert Bos, Rita Hoffman

Keynote Lunch – Partnering with your CEO
Speaker: Jack Kraeutler

GHTF Document on CAPA-Workshop
Speakers: Gina Brackett, Maria Cianciotto

510(k) – An Industry Perspective
Speakers: Mark DuVal, David Cannistraci, Dennis Hahn, Phil Phillips, Winifred Wu

Interdependency of Post-Market Surveillance, Risk and CAPA
Speakers: Monica Wilkins, Phil Pontikos

Promotional Practices – Global
Speakers: Ed Basile, Steve Silverman

FDA Inspection Trends and Office of Compliance Initiatives
Speaker: Steve Silverman

Risk Management Across the Quality Systems- Demystified
Speaker:  Phil Pontikos and Julius Aviza

Global Regulatory Strategy
Speaker: Cecilia Kimberlin

FDA Inspectional Approach
Speaker: Gina Brackett, Laureen Geniusz, Ben Dastoli, Phil Pontikos

MedCon 2012 Networking:

Between sessions, you will have the opportunity to network with members from these companies: Abbott; Abruzzo Regulatory Affairs Consulting, LLC; Advanced Sterilization Products; Alcon Laboratories; Allergan; Americas Blood Centers; Anson Group; AtriCure, Inc.; Battelle; Baxter Healthcare; Belimed Inc.; Biomet; Bio-Rad Laboratories; BNA; Boston Scientific; BSI; Carestream Health, Inc.; Cincinnati Children’s Hospital Medical Center; Cleveland FES Center Veteran Affairs; Clin Biochem Consulting; Cook Group Incorporated; Cook Medical; Covidien; Device & Implant Innovations LLC; DG Medical; DiaPharma Group, Inc.; Eagle Creek Engineering; E-BEAM Services, Inc.; Eli Lilly and Company; Ethicon Endo-Surgery; EXCMR, Inc.; FDA; FDAnews; Harvard University; Hitachi Medical Systems America, Inc.; IHL Consulting Group; Indus Pharma; Ischemia Care; ITC; Krafft Consulting Intl LLC; Mallinckrodt; Medtronic, Inc.; Meridian Bioscience, Inc.; MIDMARK Corporation; Mound Laser & Photonics Center; Neil Burris & Associates; Nobel Biocare; P&G ; Pew Charitable Trusts; Pfizer; Philips Healthcare; Procter & Gamble; Quality Alliance; Quality System Architects; Quality System Strategies LLC; QualityMetric Incorporated; REGSolutions, LLC; Regulatory & Quality Solutions; RHoffman, Inc; Roche; Roche Diagnostics; Saudi Food & Drug Authority; Sensors for Medicine and Science; SNS Nano Fiber Technology, LLC; SpineForm LLC; St. Jude Medical; Sybron Dental Specialties; The Gray Sheet; The Health Foundation; The Silver Sheet / Elsevier; TranS1; US Patent and Trademark Office; VA – FES Center; Vascular Devices, LLC.; VasoStar Inc.; Xavier University; X-spine Systems Inc.; Zimmer.

If you would like to join us, register today!


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