SQMC 2012 Agenda
Pre-Conference Workshops: Tuesday, July 31, 2012 |
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12:00 p.m. – 1:00 p.m. |
Registration and Continental Breakfast |
1:00 p.m. – 5:00 p.m. |
Medical Device Supplier Qualification and Management — Practical Approaches to Cost Effective Implementation Attendees will learn:
BONUS: Attendees will receive copies of implementation tools, including a process map, sample questionnaire, reevaluation form, audit checklist and more.
Dan O’Leary, President, Ombu Enterprises |
1:00 p.m. – 4:00 p.m. |
Do’s and Don’ts for Implementing Effective Quality Agreements Attendees will:
Alan Minsk, Partner, Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP |
DAY ONE: Wednesday, Aug. 1, 2012 |
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8:00 a.m. – 9:00 a.m. |
Registration |
9:00 a.m. – 9:15 a.m. |
Welcome and Introduction by Chairman |
9:15 a.m. – 10:00 a.m. |
Keynote: Securing the Pharmaceutical Supply Chain
This presentation will provide attendees with the latest on these fronts and what the FDA hopes it will achieve through the reauthorization of PDUFA V and other measures under consideration. |
10:00 a.m. – 10:45 a.m. |
Singing the Chain Gang Blues — Managing Risk in the Supply Chain Attendees will learn about:
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10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 12:30 p.m. |
Panel Discussion: Point/Counterpoint — Integrating the Management of Product Risk and Supplier Quality Attendees will learn:
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12:30 p.m. – 1:30 p.m. |
Lunch Break |
Track 1 — Drug |
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1:30 p.m. – 2:15 a.m. |
Qualification, Monitoring and Challenges in Working with International Suppliers Attendees will learn:
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2:15 p.m. – 3:00 p.m. |
Rogue APIs: Red Flags and Solutions Attendees will learn:
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3:00 p.m. – 3:45 p.m. |
How to Convert Supplier Quality-Related CAPA Challenges Into Tangible Benefits and Competitive Advantage Attendees will:
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3:45 p.m. – 4:30 p.m. |
Little Fish in a Big Pond: Creating Leverage with Your Supply Base Attendees will learn:
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4:30 p.m. – 4:45 p.m. |
Refreshment Break |
4:45 p.m. – 6:00 p.m. |
Panel Discussion: Strengthening the Security Chain – How to Protect Your Product from Crooked Employees, Highway Pirates, Warehouse Warriors and Other Miscreants Attendees will learn:
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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 Attendees will learn:
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2:15 p.m. – 3:00 p.m. |
Benchmark Other Industries that Use Technology to Collaborate and Monitor their Global Supply Chain This session will describe examples of companies across different industries who have addressed Supply Chain Quality challenges with state-of-the-art technology solutions. Siemens Enterasys Networks will provide a detailed case study of how it is able to:
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3:00 p.m. – 3:45 p.m. |
Anatomy of a Partnership: How to Form Strategic OEM Supply Chain Alliances or Supplier Partnerships Attendees will learn:
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3:45 p.m. – 4:30 p.m. |
Are You Ready to Serve as the Supplier Gatekeeper? 10-Point Purchasing Controls Checklist for Device Manufacturers Attendees will learn:
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4:30 p.m. – 4:45 p.m. |
Refreshment Break |
4:45 p.m. – 6:00 p.m. |
UDI Rule Coming Soon — What Does It Mean For You?
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6:00 p.m. – 7:00 p.m. |
Adjournment and Networking Cocktail Reception |
DAY TWO: Thursday, Aug. 2, 2012 |
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8:00 a.m. – 9:00 a.m. |
Registration and Continental Breakfast |
9:00 a.m. – 9:15 a.m. |
Chair Welcome and Introduction |
9:15 a.m. – 10:00 a.m. |
Current FDA Inspection, Enforcement Trends, and Field Issues Attendees will learn:
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10:00 a.m. – 10:45 a.m. |
Import Holds and Update in the FDA’s PREDICT System Attendees will learn:
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10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 12:00 p.m. |
CDER’s Expectations Regarding the Role/Accountability of Management for Supplier Oversight, Qualification and Monitoring Attendees will learn:
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12:00 p.m. |
Conference Adjourn |