FDA Field Inspectors conduct administrative and enforcement activities related to the Quality System (QS) Regulation (21 CFR 820), the Medical Device Reporting (MDR) Regulation (21 CFR 803), the Medical Device Tracking Regulation (21 CFR 821), the Corrections & Removals Regulation (21 CFR 806), and the Registration & Listing Regulation (21 CFR 807).

Under the QS regulation, manufacturers are expected to control their devices from design stage through post market surveillance. Manufacturing processes, such as sterilization, are required to be implemented under appropriate controls. The MDR, Tracking, and Corrections and Removals regulations involve activities with which manufacturers and importers are required to comply after the devices are distributed.

Before inspectors can conduct the above inspections, they are trained by the FDA on how to conduct inspections. This training program encompasses the five regulations for inspecting medical device firms.

Course Objectives:

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.

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.

Course Outline:

i) Background

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

ii) Implementation

• Objectives
• Program Management Instructions

iii) 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 Inspections

• 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

iv) Analytical

• Analyzing Laboratories
• Analyses to be Conducted
• Methodology

v) 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
• Violative 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 Followup
Exports Regulatory/Administrative Follow-up

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Managers
• Quality Engineers
• Regulatory Affairs
• Small business owners
• GxP
• Consultants
• Quality VPs
• IT VPs
• FDA investigators
• Other regulatory agency investigators