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.
Who Will Benefit:This webinar will provide valuable information to personnel in Medical Device Manufacturers including:
- R&D managers
- QA managers/staff
- Management representatives
- Members of multi-discipline design teams
- Product, project, program managers
