QSR Device Inspections – Transition from “Barely Surviving†to “Gaining Control†2010
23 Nov 2010
Webinar
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
Past Events
QSR Device Inspections – Transition from “Barely Surviving†to “Gaining Control†2010 - 23 Nov 2010, Webinar (8982)
QSR Device Inspections – Transition from “Barely Surviving†to “Gaining Control†2026
Important
Please, check "QSR Device Inspections – Transition from “Barely Surviving†to “Gaining Controlâ€" official website for possible changes, before making any traveling arrangements
