Conference Program

• 100 Marketing a Medical Device in the United States (FDA)
  
  

• 101 Risk Management for Medical Devices - Applying ISO 14971 Effectively Using Risk Assessment and Reliability Tools
  
  

• 102 Medical Device Packaging:  Regulation and Innovation

• 103 Designing a Better Medical Device

• 200 How to Quickly Discover and Respond to a Serious Product Quality Problem

• 201 Process Validation - Practical Strategies and Statistical Tools

• 202 Documentation Management for the Medical Device Industry

• 203 Product Innovation and Development

• 300 Management Responsibility and Authority

• 301 Advanced Process Validation:  Theory, Practice, Compliance

• 302 Corrective and Preventive Action:  a Practical Approach

• 303 Effective Medical Product Development
  

• 400 Advanced Good Manufacturing Practices-21 CFR, Part 820

• 401 Validation with Non-normal Data
  Note: this session ends
  at 1:00 pm.

• 402 MultiPhase Polymer Systems and Their Application in Medical Devices (SPE)
  
  

• 403 Medical Device Design Transfer as a Process
  Note: this session ends
  at 1:00 pm.

Conference registration includes:

• Lunch on registered day(s)
• A CD containing materials for registered day(s) and a set of proceedings for registered session(s)
• Coffee and refreshments during the session breaks
• Complimentary admission to the expo