Supplier Quality Management Congress Presentations

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Pre-Conference Workshop: Tuesday, July 31, 2012

1:00 p.m. – 5:00 p.m.

Medical Device Supplier Qualification and Management — Practical Approaches to Cost Effective Implementation

Dan O’Leary, President, Ombu Enterprises
John Avellanet, Principal Consultant, Cerulean Associates (Co-chair)

1:00 p.m. – 4:00 p.m.

Do’s and Don’ts for Implementing Effective Quality Agreements

Alan Minsk, Partner, Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP
Lynn Scott, Partner, Corporate Practice Team, Arnall Golden Gregory LLP

DAY ONE: Wednesday, Aug. 1, 2012

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

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

Jennifer Zachary, Associate, Food and Drug Practice Group, Covington & Burling LLP

3:00 p.m. – 3:45 p.m.

How to Convert Supplier Quality-Related CAPA Challenges Into Tangible Benefits and Competitive Advantage

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

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
A Case Study with Siemens Enterasys Networks

Fred Malcolm, Director of Quality Engineering, Siemens Enterasys Networks
Jason Spiegler, Director, Quality Engineering, Camstar Systems, Inc.

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
Bob Khin, Quality Assurance Director, Banner Medical
Vince Adams, Vice President for Sales, Marketing & Strategic Planning, Banner Medical

3:45 p.m. – 4:30 p.m.

Are You Ready To Serve As The Supplier Gatekeeper? 5-Point Purchasing Controls Checklist For Device Manufacturers

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
Jay Crowley, Senior Advisor for Patient Safety, CDRH, FDA
Siobhan O’Bara, Vice President, GS1 Healthcare
Dan O’Leary, President, Ombu Enterprises

DAY TWO: Thursday, Aug. 2, 2012

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