FDA Inspection and Medical Device Design Control 2015

Topics

• Definitions
• Applicable Laws and Regulations
• Design and Development Planning
• Design Control Requirements
• Design Review
• Design Input and Design Output
• Design Transfer and Design Changes
• Design Verification And Validation
• FDA Inspection for Design Control
• Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR)
• How to Prepare for FDA inspection for Design Control
• Common Mistakes and How to Avoid
• Best Practices for Establishing and Maintaining a Design Control System

Who should Attend

Senior attendees with job titles such as:

• Quality
• R&D
• Compliance Officers
• Regulatory Affairs
• VPs
• CEOs
• Complainant Managers
• Attorneys
• Consultants
• Managers (RA, QA/QC, CA)
• Anyone interested in the topic
• Contractors and Subcontractors