3 Hour Webinar: How the FDA is Trained on Medical Device Inspections

12:00 PM EDT | 9:00 AM PDT | 11:00 AM CDT Duration 180 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 3 Hrs Live Webinar

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

This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms


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 postmarket 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 encompases 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

I. Background
    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
II. Implementation
    A. Objectives
    B. Program Management Instructions
III. 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
IV. Analytical
  A. Analyzing Laboratories
  B. Analyses to be Conducted
  C. Methodology
V. 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
     Quality Managers
     Quality Engineers
     Regulatory Affairs
     Small business owners
     Quality VPs
     IT VPs
     FDA investigators
     Other regulatory agency investigators

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, Biotechnology,Pharmaceutical 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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