MD&M Minneapolis 2009
Session 200—The Future Is Now: Anticipating a New Era of FDA Enforcement (continued)
FDA Enforcement Trends: Leading Types of Quality System Deficiencies Noted during 2009 FDA Inspections, and What This Means for FDA Enforcement Programs
Keisha Thomas, FDA
Quality Problem Investigations & Root Cause Analysis: U.S. FDA Requirements and the Changing Enforcement Environment
Michael Barile, Barile & Associates Inc.
A New Approach to Automating Your Quality Management System
John (Jack) Garvey, Compliance Architects LLC
Lessons Learned: How Product Failures, Recalls, and GMP/QSR Problems Trigger FDA Enforcement Actions
Kathy DePadua, Philips Home Healthcare Solutions
Session 201—Managing Challenges in the Supply Chain
Chair: Steven Walfish, Statistical Outsourcing Services
Managing the Supply Chain
Susan Reilly, Reilly & Associates LLC
Environmental Concerns in the Supply Chain
Aimee Siegler, Benchmark Electronics
Purchasing Controls—How to Avoid a Warning Letter
Michael Heyl, Hogan & Hartson LLP
Outsourcing and the Virtual Manufacturer
Barry Craner, Lipid Sciences
Lean Enterprise Drives Improvements across Medical Device Supply Chain
Leo Barry, Plexus Electronic Assembly
Supplier Evaluation
Steven Walfish, Statistical Outsourcing Services
Case Study: Evaluate and Make Recommendations from Four Different Perspectives: Small Virtual Company, Large Global Manufacturer, Regulatory, and Suppliers
Steven Walfish, Statistical Outsourcing Services; and Sue Jacobs, QMS Consulting Inc.
Session 202—Process Validation: Solutions and Strategies for the Medical Device Industry
Instructor: Vinny Sastri, Winovia LLC
Morning
• FDA Quality System Regulations and Process Validation
• Validation Planning and Validation Master Plans
• Process Validation and Design Control
• Risk Analysis
• Validation and Verification
• Installation Qualification
Afternoon
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Statistical Tools and Techniques
• Sampling Plans
• Process Control
• Maintaining a Validated State
• Validation Life Cycle
• Documentation, Protocols, Reports, and Reviews
Session 203—Product Development Process for Medical Devices
Chairs: H. Semih Oktay, CardioMed Device Consultants LLC; and Nitin Salunke, W. L. Gore and Associates Inc.
Product Development Process
John Avi Roop, Stanford Biodesign Program, James H. Clark Center
Intellectual Property Considerations During Product Development
Christopher J. Buchko, PhD, McAndrews Held & Malloy Ltd.
Panel Discussion
Faculty
Preclinical Evaluation: In Vitro and In Vivo Testing
Santosh Prabhu, Abbott Vascular
Regulatory and Clinical Considerations
H. Semih Oktay, CardioMed Device Consultants LLC; and Dawn Stenstrom, Medtronic
Panel Discussion and Wrap-Up
All speakers and cochairs, Q&A session
