MD&M Minneapolis 2009
Click here for an updated list of conference sessions at MD&M Minneapolis
Tuesday, October 20
Session 100
The Future Is Now: Anticipating a New Era of FDA Enforcement
Chair: Michael Barile, Barile & Associates
Change at FDA: How Will This Change Affect FDA’s Expectations for Your Quality System?
Don Abbey, CareFusion
How Will FDA’s Changing Expectations Impact Management’s Responsibility?
Brian R. Burns, Boston Scientific Corp.
How Will FDA’s Changing Expectations Impact Quality Management of Outsourced and Offshore Manufacturing?
John (Jack) Garvey, Compliance Architects
• Evolution of Corporate Outsourcing/Offshoring
• Types of External Relationships
• Contracts/Agreements—The Core of the Relationship
• The Communications Conundrum
• Issues for FDA-Regulated Manufacturers
• FDA’s “New” Approach to Supply-Chain Management Expectations
What Are FDA’s Changing Expectations for Integrating Risk Management into Your Quality Management System?
Michael Barile
Session 101
Managing Challenges in the Supply Chain
Chair: Sue Jacobs, QMS Consulting Inc.
Supplier Controls: An FDA Perspective
Keisha Thomas, FDA
• GHTF Overview
• Risk Associated with Suppliers
• SG3 Guidance—Control of Products or Services from Suppliers Highlighted
• Recommendations for Manufacturers
Risk in the Supply Chain
Bruce Hagger, Med-Q Systems
• When and How to Apply Risk in the Supply Chain
• Challenges and Tips to Overcome Them
• How to Utilize Risk with Supplier Performance or Single-Source Issues
• Risk/Benefit—How to Integrate in Supply-Chain Management
Global Supply Chain
Jon Mulberg, LifeScan
• What Should Be Considered?
• What Are Challenges?
• Communication and Consistency
A Small Supplier Perspective
Francine Lasky, Scientific Device Laboratory
Facing the Challenges—Panel Discussion
Session 102
Design Testing: Achieving Optimal Results with Less Effort
Chair: Andrew Snow, Momentum Solutions
Understanding the Path to Optimal Results
Andrew Snow
• Overview of the Day Ahead
• Understanding Verification and Validation Requirements
• The Issues that Prevent Effective Results
• Mastering the Three R’s: Repeatability, Reproducibility, and Reliability
• Strategies for Optimizing Results
Using Risk-Based Methods to Drive Efficient, Compliant Product Verification
Todd Hansell, Covidien
Software Validation Tools for Discovering Hidden Quality Problems
David James, Precision V&V Services
Strategies for a Successful Usability Verification Test
Anne Mickelson, Minnetronix
• Integrating the Task Analysis into the Usability Test
• Identifying Use Errors and Hazards
• Presentation of Case Studies
Wrap-Up Q&A and Panel Discussion
Session 103
Due Diligence in Product Development: Early and Sustained Activity
Chair: Les Halberg
Technology Diligence
Chris Reiser, Boston Scientific Corp.
Market and Business Diligence
Carla Mann Woods, Alfred Mann Foundation; and Nancy Patterson, President Strategy Inc.
Reimbursement Diligence
Nancy Reaven, Strategic Health Resources
Regulatory Diligence
Russell W. Olson, Regulatory and Clinical Research Institute Inc.
Clinical/Preclinical Diligence
Nancy Stark, Clinical Device Group
IP Diligence
Invited Speaker
• How Does Intellectual Property Activity Contribute to Success?
• Valuation
• Brainstorming throughout the Product Development Life Cycle as New Knowledge Is Gained
