Supplier Quality Management Congress Presentations
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Pre-Conference Workshop: Tuesday, July 31, 2012 |
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1:00 p.m. – 5:00 p.m. |
Dan O’Leary, President, Ombu Enterprises |
1:00 p.m. – 4:00 p.m. |
Do’s and Don’ts for Implementing Effective Quality Agreements |
DAY ONE: Wednesday, Aug. 1, 2012 |
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9:15 a.m. – 10:00 a.m. |
No Excuses: How the FDA Expects You to Manage Your Supply Chain Denise Dion, Vice President of Regulatory and Quality Services, EduQuest |
10:00 a.m. – 10:45 a.m. |
Singing The Chain Gang Blues — Managing Risk in the Supply Chain Sara Dyson, Assistant Vice President, Medmarc Insurance Group |
11:00 a.m. – 12:30 p.m. |
Point/Counterpoint — Integrating the Management of Product Risk And Supplier Quality Jonathan Lee, President, Medical Device Consulting Solutions International |
Track 1 — Drug |
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1:30 p.m. – 2:15 a.m. |
Qualification, Monitoring and Challenges in Working with International Suppliers John Avellanet, Principal Consultant, Cerulean Associates |
2:15 p.m. – 3:00 p.m. |
Rogue APIs: Red Flags and Solutions |
3:00 p.m. – 3:45 p.m. |
Michael Causey, Analyst, FDAnews and Nikki Willet, Accenture |
3:45 p.m. – 4:30 p.m. |
Warning Letters as Teaching Lessons — Understanding What The FDA’s Thinking Is And Why Denise Dion, Vice President of Regulatory and Quality Services, EduQuest |
Track 2 — Device |
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1:30 p.m. – 2:15 p.m. |
Got Bloated Supplier Lists? Applying Lean Principles to Supplier Assessment Criteria Sean Ryan, Global Supplier Quality Manager, Welch Allyn |
2:15 p.m. – 3:00 p.m. |
Benchmark Other Industries that Use Technology to Collaborate and Monitor their Global Supply Chain
Fred Malcolm, Director of Quality Engineering, Siemens Enterasys Networks |
3:00 p.m. – 3:45 p.m. |
Anatomy of a Partnership: How to Form Strategic OEM Supply Chain Alliances or Supplier Partnerships
Peter Johns, Supplier Quality Manager, Pioneer Surgical |
3:45 p.m. – 4:30 p.m. |
Mike Heyl, Partner, Hogan Lovells, Washington, DC |
4:45 p.m. – 6:00 p.m. |
Device Panel Discussion: UDI Rule — What Does It Mean For You?
Moderator: Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding |
DAY TWO: Thursday, Aug. 2, 2012 |
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9:15 a.m. – 10:00 a.m. |
Current FDA Inspection, Enforcement Trends, and Field Issues Melissa Torres, Biomedical Engineer, Office of Compliance, CDRH, FDA |
10:00 a.m. – 10:45 a.m. |
Import Holds and Update in the FDA’s PREDICT System Casper Uldriks, Counsel, Olsson Frank Weeda Law |