Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs 2014

Key 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.