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

This training program will give participants an insight into how inspectors think when they come for an inspection. It will explain not just the how, but the why of a successful inspection. It encompasses the five regulations for inspecting medical device firms.

Angela Bazigos
Instructor:
Angela Bazigos
Date:
Thursday, October 24, 2019
Time:
09:00 AM PDT | 12:00 PM EDT
Duration:
3 Hours

More Trainings by this Expert   Product Id : 502755

Price Details
$290 Live
$490 Corporate Live
$340 Recorded
$540 Corporate Recorded
Combo Offers
Live + Recorded
$549 $630 Live + Recorded
Corporate (Live + Recorded)
$799 $1030 Corporate
(Live + Recorded)
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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 violative 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
      • 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

Who Will Benefit:
  • Quality Managers
  • Quality Engineers
  • Regulatory Affairs
  • Small Business Owners
  • GxP
  • Consultants
  • Quality VPs
  • IT VPs
  • FDA Investigators
  • Other Regulatory Agency Investigators


Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training 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 LifeSciences.




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