How the FDA are Trained for Medical Device Inspections

12:00 AM ET | 9:00 AM PT| 1 1:00 AM CT Duration 180 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and180 mins Live FDA Webinar

"Listen from Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

Listing Regulation (21 CFR 807)


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. 

Why should you attend

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.


Areas Covered

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

1. Quality System Inspection Technique (QSIT)

A. The Quality System (QS) Regulation

B. The MDR Regulation

C. The Medical Device Tracking Regulation

D. The Corrections and Removals Regulation

E. The Registration and Listing Regulation


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

2. Implementation

        A. Inspector’s Objectives

        B. Program Management Instructions

3. Inspectional

        A. Operations

                1. Inspectional Strategy

                      a) QS inspections

                      b) Level 1 Inspections

                      c) Level 2 Inspections

                      d) Level 3 Inspections

                      e) For Cause Inspections

                      f) Risk Based Work Plan Inspections

                      g) Foreign Inspections

                2. Inspectional Instructions

                      a) Special Instructions Concerning Design Control

                      b) Special Instructions Concerning Design Controls

                      c) Special Instructions for Sterilization Processes

                      d) Inspection of Radiation Emitting Devices

                      e) Sample Collection

        B. Additional Considerations

                      1. Registration and Listing

                      2. Imports

                      3. Exports

                      4. Electronic Records and Electronic Signatures

        C. Remarketed Devices

        D. Reporting

4. Analytical

        A. Analyzing Laboratories

        B. Analyses to be Conducted

        C. Methodology


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 violative devices and finally what administrative and / or legal actions need to be taken. Discussion of recidivist violators will be included. 

5. Regulatory/Administrative Follow-up

        A. Quality System/GMP Regulatory/Administrative Follow-up

                     1. Compliance Decision

                     2. Contract Sterilizers, Contract Device Manufacturers and

                     3. Finished Device Manufacturers – Deciding Responsibility

                     4. When Taking Regulatory Action

                     5. 3. Violative Devices Sold to Government Agencies

                     6. 4. Administrative and Judicial Actions

                     7. 5. Facilitating Review of Regulatory Recommendations

        B. MDR Regulatory/Administrative Follow-up

        C. Tracking Regulatory/Administrative Follow-up

        D. Corrections and Removals Regulatory/Administrative Follow-up

        E. Registration and Listing Regulatory/Administrative Follow-up

        F. Radiation Emitting Device Regulatory/Administrative Followup

        G. Exports Regulatory/Administrative Follow-up


Who will Benefit

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


Industries who can attend

This 180-minute online course is intended for professionals in the Medical device Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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