SQMC 2010 Agenda
Pre-Congress Workshop |
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12:00 p.m. – 1:00 p.m. |
Pre-Congress Workshop Registration |
1:00 p.m. – 5:00 p.m. |
Workshop A: Creating Comprehensive Medical Device Supplier Quality Agreements That Reduce Risk and Improve Contract Deliverables
Dan O’Leary, President, Ombu Enterprises |
1:00 p.m. – 5:00 p.m. |
Workshop B: Creating Pharmaceutical Supplier Quality Agreements Attendees will:
John Vajda, Managing Consultant, BFC Consultants |
DAY ONE |
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8:15 a.m. – 9:00 a.m. |
Registration and Continental Breakfast |
9:00 a.m. – 9:15 a.m. |
Welcome and Introduction by Chairman John Avellanet, Managing Director, Principal Consultant, Cerulean Associates |
9:15 a.m. – 10:15 a.m. |
Catching Up to 21st-Century Challenges: FDA’s Supplier Quality and Compliance Outlook Carmelo Rosa, Division of Manufacturing & Product Quality, CDER, FDA |
10:15 a.m. – 11:00 a.m. |
Inside the Development of GHTF SG3 — Managing Internal and External Suppliers Kimberly Trautman, Medical Device Quality System Expert, Office of Compliance, CDRH, FDA |
11:00 a.m. – 11:15 a.m. |
Networking and Refreshment Break |
11:15 a.m. – 5:00 p.m. |
Two Concurrent Breakout Tracks
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Track 1 — Medical Device |
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11:15 a.m. – 11:30 a.m. |
Medical Device Track Chair Comments John Avellanet, Managing Director, Principal Consultant, Cerulean Associates |
11:30 a.m. – 12:15 p.m. |
Establishing a Supplier Corrective Action Report (SCAR) Process Attendees will:
Steve Niedelman, Senior Consultant, Crowell & Moring |
12:15 p.m. – 1:00 p.m. |
Assessment Tool for Choosing the Right Subcontractor or Supplier Attendees will:
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1:00 p.m. – 2:00 p.m. |
Lunch |
2:00 p.m. – 2:45 p.m. |
Developing Supplier Quality Auditor Training Programs — Tips and Tricks Revealed Attendees will:
Seth Mailhot, Latham & Watkins LLP; Former Compliance Officer and Medical Device Inspector, New England District Office, FDA |
2:45 p.m. – 3:30 p.m. |
Outsourcing Industry Trends: What Device Companies Are Doing to Make the Difference Attendees will:
John Avellanet, Managing Director, Principal Consultant, Cerulean Associates |
3:30 p.m. – 3:45 p.m. |
Networking and Refreshment Break |
Track 2 — Drug and Biologic |
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11:15 a.m. – 11:30 a.m. |
Drug and Biologic Track Chair Comments Jim Darnell, Managing Consultant, Tunnell Consulting |
11:30 a.m. – 12:15 p.m. |
Rogue APIs: Red Flags and Solutions Attendees will:
Huascar Batista, Team Leader of the Office of Compliance's Import-Export Team, FDA |
12:15 p.m. – 1:00 p.m. |
Case Study: Melamine Quality Risk Management Attendees will:
Londa Ritchey, Director Supplier Quality, Pfizer |
1:00 p.m. – 2:00 p.m. |
Lunch |
2:00 p.m. – 2:45 p.m. |
Creating Effective Supplier Qualification Management Systems For Drugs and Biologics Attendees will:
Peter Calcott, President, Calcott Consulting |
2:45 p.m. – 3:30 p.m. |
Selection, Qualification, and Monitoring of Third Party Logistics Providers (3PLs): Strengthening the Cold Chain Attendees will:
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3:30 p.m. – 3:45 p.m. |
Networking and Refreshment Break |
3:45p.m. – 5:00p.m. |
Working With Suppliers: Dispel Industry Myths Panel Discussion
Moderator: John Avellanet, Managing Director, Principal Consultant, Cerulean Associates |
5:00 p.m. – 6:30 p.m. |
Adjournment and Networking Reception |
DAY TWO |
|
8:00 a.m. – 8:45 a.m. |
Continental Breakfast |
8:45 a.m. – 9:00 a.m. |
Welcome and Introduction by Chairman Jim Darnell, Managing Consultant, Tunnell Consulting |
9:00 a.m. – 10:00 a.m. |
International Perspective On Supply Chain Complexity Mark Mansour, Partner, Bryan Cave LLP |
10:00 a.m. – 11:00 a.m. |
Strategies for Reducing Supply Chain Risk through Real-Time Visibility & Collaboration — A Case Study
Al Alaverdi, Sr. Supply Chain Quality Solution Consultant, Camstar Systems, Inc. |
11:00 a.m. – 12:00 p.m. |
Pharma and Device “Put Away the PowerPoint” Panel Discussion and Closing Comments
Moderator: Jim Darnell, Managing Consultant, Tunnell Consulting |