Topics
- Corrective And Preventive Action (CAPA) And Complaint Files
- Device History Record (DHR) And Device Master Record (DMR)
- Definitions
- Applicable Laws
- Frequent Citations in 483s and How to Avoid
- Quality System Procedures, Purchasing Controls And Servicing
- FDA Quality System Regulations
- Process Validation
- Top 20 Items Cited in 483s
- Design History File (DHF)
- Mistakes While Implementing QSRs
- Inspection, Measuring And Test Equipment
- How to Avoid Mistakes
- Quality Requirements For Premarket Approval (PMA) Application
- Design Control: Design And Development Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, And Design Changes
Who should Attend
VPs, CEOs, Attorneys, Compliance Officers, Managers (RA, QA/QC, CA), R&D and Manufacturing Managers, Contractors and Subcontractors and Consultants.
