QSR Device Inspections - Transition from ''Barely Surviving'' to ''Gaining Control''
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.
Why Should You Attend:
Your newly approved device is now on the market and is undergoing mass production at your manufacturing facility. What’s next? Now, you as device manufacturer are subject to an additional set of FDA requirements known as Quality System Regulations (QSR) and FDA can schedule an inspection at any time. Quality System inspections, to the unprepared, can be seen as an overwhelming and intimidating experience; however, understanding the overall purpose of a Quality System and establishing a quality system that will meets FDA’s expectation before the inspection occurs is a critical step to transitioning from “barely surviving” to “gaining control”.
The 1st hour of this webinar will introduce and provide an overview of the quality system regulation and FDA requirements expected of device manufacturers. The 2nd hour of this webinar will provide an overview of Quality System Inspections and cover techniques used by FDA Investigators that will help start-up, small and midsize device manufacturers effectively prepare for upcoming Quality System 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
Kimberly Kiner, BSc, CCRA is the President of 2K Clinical Consulting, Inc. a niche provider that focuses on simplifying trial management by providing monitoring, co-monitoring, and auditing services to sponsor companies, CROs and sponsor-investigators. She has 13+ years of experience in the regulatory/ quality assurance and clinical research industry. She started her career at FDA as a GMP investigator specializing in Medical Devices. She later transitioned into the GCP industry working for CRO and sponsor companies and has held many positions over the years in CRA, auditor and other managerial roles. She has a diverse experience in therapeutic areas of Medical devices, InVitro diagnostics, Cardiovascular, CNS, Infectious Diseases, Gastroenterology, Endocrinology and Women’s Health.