Presentations
FDA/Xavier University Medical Device Conference, May 4-7, 2010
Conference Presentations
MedCon 2010 is proud to feature some of the foremost thought leaders in the Medical Device Industry. As a courtesy to our attendees, we have included their presentations, below. If you have any questions or need more information please contact Marla Phillips by email or phone 513 745-3073.
MedCon Track Newsletters
Brief notes and overviews of the track sessions by Michelle Smith, Chris Ross, Jodi Wince and Susan Rolih of Meridian Bioscience, Inc.
MedCon Day 1 Presentations
Plenary
Keynote Presentation, Steven Silverman
Global Compliance, Kim Trautman
Track Sessions
Quality
2009 Warning Letter and 493 Trends, Kim Trautman
Building Effective Supplier Control Programs and Reducing Risk, Steven Niedelman
What Happens After An FDA Inspection? part 1, Virginia Connelly
What Happens After An FDA Inspection? part 2, Stephen Rabe
Medical Device Reporting (MDR)/Electronic Report Submissions (eMDR), Sharon Kapsch
Regulatory
Regulatory Impact of Design and Process changes, Phillip Pontikos and Sheila Hemeon-Heyer
Corrections and Removals, Gina Brackett
Clinical
Integrating Internal and External Resources For Clinical Trials, Sheryl Helsinger
Innovative Clinical Study Design, Jeremy Jokinen
Introduction to Bayesian Analysis, Gary Stevens
Challenges in Conducting Global Clinical Trials, Danielle Giroud
MedCon Day 2 Presentations
Plenary
GHTF SG3 Documents, Kim Trautman
Global Harmonization, Jos Kraus
Global Harmonization, Industry Perspective, Tim Missios
Tracks
Complaints and Complaint Investigations, Phillip Pontikos
Recalls and Corrections and Removals, Monica Wilkins
Integrated Product Lifecycle Risk Management for Combination Products, Francis Blacha
On CAPA and Investigations, Barbara Immel
Regulatory
Building Effective Supplier Control Programs and Reducing Risk, Paul Brooks
Combination Products, Ken Charak
Promotion and Advertising of Medical Devices, Deborah Wolf
Clinical
Current Trends in EDC for the Device Industry, Suzanne Lamerand
Use of Computerized Systems in Device Clinical Investigations, Jonathan Helfgott
EHR Based Image and Data management for Clinical Trials, Rainer Waedlich
Joint Clinical/Regulatory Session, Kenneth Sumner
MedCon Day 3 Presentations
Reimbursement Process and Healthcare Reform, Tom Ruthemeyer and Patrick Redmon
Asian Harmonization Working Party, Jack Wong
Comparison of Design Master File and Technical File Requirements, Carole Stamp
