This Medical Device Quality System training will discuss how to Create an adequate quality system that meets FDA’s requirements and Effectively prepare for upcoming Quality System Regulation (QSR) inspections.
 
Areas Covered in the Seminar:

• Definition of Quality System Regulations (QSR).
• Who must comply fully vs who is allowed to partially comply to QSR.
• Definition of QSR’s four main subsystems:
  • Management Control
  • Corrective and Preventive Action (CAPA)
  • Design Controls
  • Production and Process Controls (P&PC)
• Definition of Satellite subsystems.
  • Medical Device Reporting
  • Corrections and Removals
  • Medical Device Tracking
  • Sterilization Process Controls
• Tips on establishing an effective quality system for the design, production and distribution of your device.
• Overview of Quality System Inspection Technique.
• Typical Quality System deficiencies noted in Warning letters.
• Techniques used in inspection planning.
• Factors involved in selection process.
• Overview of FDA regulations and guidelines used for inspections.
• Inspection documentation and proper follow-up procedures.
• Tips for Preparing for Quality System Inspection/