3-Hour Virtual Seminar on Bootcamp on How the FDA are Trained for Medical Device Inspections - Webinar (Recorded)

Overview:
This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms. It will present the specific guidance FDA inspectors receive for each of the regulations.

Why should you Attend: As a result, attendees will understand not only what they need to do to set up their company for a successful inspection, but also WHY they need to do it. They will get insight into the workings of the inspectors' mind to understand what they are looking for during an inspection.

Areas Covered in the Session:

Session #: 1
Duration: 1 hour

Learning Objectives: Fundamental information about the Quality System Inspection Technique used by FDA, and the associated subsystems: Major and Minor. How inspection of the subsystems forms the building blocks for each inspection. Inspection objectives and inspection process for each subsystem will be discussed

• Quality System Inspection Technique (QSIT)
• The Quality System (QS) Regulation
• The MDR Regulation
• The Medical Device Tracking Regulation
• The Corrections and Removals Regulation
• The Registration and Listing Regulation

BREAK

Session #: 2
Duration: 1 hour 15 minutes

Learning Objectives: This part will give high level description of the regulations that are addressed, and will discuss the inspector's objectives in assessing compliance as well as the instruction they would receive from the FDA to go ahead with the inspection. The session will then delve into details as to how the subsystem building blocks from the previous session are used to conduct the inspections. Which parts and how to use the subsystems and what to report, will be discussed

• Implementation
• Inspector's Objectives
• Program Management Instructions
• Inspectional
• Operations
• Inspectional Strategy
• QS inspections
• Level 1 Inspections
• Level 2 Inspections
• Level 3 Inspections
• For Cause Inspections
• Risk Based Work Plan Inspections
• Foreign Inspections
• Inspectional Instructions
• Special Instructions Concerning Design Control
• Special Instructions Concerning Design Controls
• Special Instructions for Sterilization Processes
• Inspection of Radiation Emitting Devices
• Sample Collection
• Additional Considerations
• Registration and Listing
• Imports
• Exports
• Electronic Records and Electronic Signatures
• Remarketed Devices
• Reporting
• Analytical
• Analyzing Laboratories
• Analyses to be Conducted
• Methodology

BREAK

Session #: 3
Duration: 45 minutes

Learning Objectives: When things go wrong during an inspection, the FDA conducts administrative follow up both in terms of alerting the device manufacturer, and ensuring that the manufacturer resolves the issue. This part will discuss how FDA determines who should be held accountable for the issue, how violations for each subsystem are handled, how to handle volitive devices and finally what administrative and/ or legal actions need to be taken. Discussion of recidivist violators will be included.

• Regulatory/Administrative Follow-up
• Quality System/GMP Regulatory/Administrative Follow-up
• Compliance Decision
• Contract Sterilizers, Contract Device Manufacturers and
• Finished Device Manufacturers – Deciding Responsibility
• When Taking Regulatory Action
• Volitive Devices Sold to Government Agencies
• Administrative and Judicial Actions
• Facilitating Review of Regulatory Recommendations
• MDR Regulatory/Administrative Follow-up
• Tracking Regulatory/Administrative Follow-up
• Corrections and Removals Regulatory/Administrative Follow-up
• Registration and Listing Regulatory/Administrative Follow-up
• Radiation Emitting Device Regulatory/Administrative Follow-up
• Exports Regulatory/Administrative Follow-up