SQMC 2011 Agenda
Revised as of July 25, 2011 Pre-Conference Workshop: Tuesday, Aug. 9, 2011 |
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12:00 p.m. – 1:00 p.m. |
Registration and Continental Breakfast |
1:00 p.m. – 5:00 p.m. |
WORKSHOP A: Medical Device Supplier Qualification and Management — Practical Approaches to Cost Effective Implementation
You can start to prepare with important GHTF guidance documents: Control of Suppliers (GHTF/SG3/N17:2008), Risk Management Principles in a QMS (GHTF/SG3/N15R8), and Corrective Action & Preventive Action in a QMS (GHTF/SG3/N18:2010). These guidance documents provide the foundation, but lack practical details. This workshop gives you the tools and methods you need for a cost effective implementation.
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. – 5:00 p.m. |
WORKSHOP B: Creating Pharmaceutical Supplier Quality Agreements Attendees will:
Steven Sharf, President, GMP Concepts (Co-chair) |
DAY ONE: Wednesday, Aug. 10, 2011 |
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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 John Avellanet, Managing Director, Principal Consultant, Cerulean Associates |
9:15 a.m. – 10:00 a.m. |
Opening Keynote: Supplier Controls — The Latest FDA Medical Device Requirements Attendees will learn:
Kimberly Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH, FDA |
10:00 a.m. – 10:45 a.m. |
The GHTF Document on Supplier Controls Kimberly Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH, FDA |
10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 12:30 p.m. |
Panel Discussion: Supplier Quality Agreements – Five Lessons Learned and Five Mistakes to Avoid
Panelist: Hidee Molina, Division of Manufacturing and Product Quality, CBER, FDA |
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. |
Lessons Learned from Recent Recalls and Defective Product Cases This presentation offers an opportunity to hear an expert analysis of recent cases and how you can learn from the mistakes of others. Steven Niedelman, Lead Quality System & Compliance Consultant, King & Spalding LLP |
2:15 p.m. – 3:00 p.m. |
Writing A Robust Audit Observation That Suppliers Can Actually Understand and Use Attendees will learn:
Steven Sharf, President, GMP Concepts |
3:00 p.m. – 3:45 p.m. |
Real-Time Risk Profiles of GMP Material Suppliers — An Essential Supplier Quality Risk Management Tool Attendees will learn:
Londa Ritchey, Director, Supplier Qualification, Pfizer |
Track 2 — Device |
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1:30 p.m. – 2:15 p.m. |
Do’s and Don’ts for Implementing Effective Quality Agreements Attendees will learn:
Alan Minsk, Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP |
2:15 p.m. – 3:00 p.m. |
Auditing Your Entire Supplier Base Once A Year — Benchmarks for Success Attendees will learn:
Anthony Pavel, Partner, K&L Gates |
3:00 p.m. – 3:45 p.m. |
Supplier Management and the FDA Attendees will learn:
Susan Reilly, President, Reilly and Associates |
3:45 p.m. – 4:00 p.m. |
Refreshment Break |
4:00 p.m. – 5:30 p.m. |
Panel Discussion: Working with Suppliers — Dispelling Industry Myths
Panelist: William Reiss, Senior Quality
Agreements and Sample Retention, Celgene |
5:30 p.m. – 6:30 p.m. |
Adjournment and Networking Cocktail Reception |
DAY TWO: Thursday, Aug. 11, 2011 |
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8:00 a.m. – 9:00 a.m. |
Registration and Continental Breakfast |
9:00 a.m. – 9:05 a.m. |
Chair Welcome and Introduction |
9:05 a.m. – 9:45 a.m. |
Import Holds and Update in the FDA’s PREDICT System Attendees will learn:
Benjamin England, Esq., Founder, FDA Imports |
9:45 a.m. – 10:25 a.m. |
Qualification, Monitoring and Challenges in Working with International Suppliers This presentation will discuss some common challenges in working with international suppliers and best practices for overcoming these challenges. Attendees will learn:
Elaine Dymond, Vice President of Quality, Catelent Pharma |
10:25 a.m. – 10:35 a.m. |
Refreshment Break |
10:35 a.m. – 11:15 a.m. |
Trust But Verify: A Look At How Other Industries Use Technology to Monitor Supplier Quality In Real Time In this session you will learn how leading brand owners across different industries are using state-of-the art technology to monitor and collaborate with globally dispersed sites, suppliers and contract manufacturers to improve product quality and reliability. You'll hear how these companies are solving real challenges such as ensuring product quality at contract manufacturers in Asia, detecting unauthorized supplier changes, reducing supplier variability in a new product launch, detecting a counterfeit operation, and many others. Jason Spiegler, Director, Business Development, Camstar Systems, Inc. |
11:15 a.m. – 11:55 a.m. |
Managing Risk in the Supply Chain Attendees will learn:
Sara Dyson Esq., Loss Control Manager, Medmarc Insurance Group |
12:00 p.m. |
Conference Adjourn |