FDA Inspection and Medical Device Design Control 2015 covers topics such as:
- 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
FDA Inspection and Medical Device Design Control 2015 brings together 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