CDRH Learn: Global Harmonization: Single Audit Program

By Effective Medicine  On  In Medical Devices Tagged  

Listed below are the courses CDRH currently offers. Additional online courses are being developed and will be posted upon completion. 

Course List

  • Overview of Regulatory Requirements: Medical Devices
  • Premarket Notification Process – 510(k)
  • Investigational Device Exemption Process – IDE [New! 7/6/2011]
  • Bioresearch Monitoring (BIMO)
  • Device Establishment Registration and Listing
  • CDRH Regulated Software: An Introduction
  • Quality System Regulation 21 CFR Part 820
  • Medical Device Recalls [New! 6/1/2011]
  • Medical Device Reporting (MDR)
  • Export Certificates for Medical Devices
  • Regulation of Radiation-Emitting Products
  • Global Harmonization: Single Audit Program – Quality Management System Audit Reports (GD211) [New! 7/29/2011]
  • Future Course Topics

Overview of Regulatory Requirements: Medical Devices

Overview of the Premarket Notification Process – 510(k)

510(k) Overview

Product Codes Making the Connection…

510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)

510(k) User Fees

510(k) Third Party Review

“513(g)s”.. Including 513(g) User Fees

Post Test for all 510(k) Modules

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Investigational Device Exemption Process – IDE

Idea to IDE: A Medical Device in the Making

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Bioresearch Monitoring (BIMO)

BIMO Part 1a – Good Clinical Practice 101: An Introduction

BIMO Part 1b – Introduction to the Bioresearch Monitoring Program

BIMO Part 2a – The Sponsor: Responsibilities in Medical Device Clinical Trials

BIMO Part 2b – The Clinical Investigator: Responsibilities in Medical Device Trials

BIMO Part 2c – Computerized Systems Used in Medical Device Clinical Investigations

BIMO Part 3a – Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination

BIMO Part 3b – Institutional Review Board: Humanitarian Use Devices (HUDs)

BIMO Part 3c – Institutional Review Board: Compassionate and Emergency Use

BIMO Part 4a – Preparing for an FDA Medical Device Sponsor Inspection

BIMO Part 4b – Preparing for an FDA Clinical Investigator Inspection

BIMO Part 4c – Preparing for an FDA Institutional Review Board Inspection

BIMO Part 5a – Strategies for Sponsors to Build Quality into Device Research

BIMO Part 5b – Strategies For Clinical Investigators to Build Quality into Device Research

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Device Establishment Registration and Listing

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CDRH Regulated Software: An Introduction

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Quality System Regulation 21 CFR Part 820

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Medical Device Recalls

Introduction to Medical Device Recalls: Industry Responsibilities

Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals

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Medical Device Reporting (MDR)

MAUDE – Information Available to the Public

Electronic Medical Device Reporting (eMDR)

Medical Device Reporting

MDR for User Facilities

MDR for Manufacturers and Importers

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Export Certificates for Medical Devices

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Regulation of Radiation-Emitting Products

How to Get Your Electronic Product on the U.S. Market

Phantom Image Scoring (For MQSA Inspectors)

eSubmitter Tutorial Videos

  • eSubmitter Tutorial Videos
  • Radiological Health Report Tutorial

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Global Harmonization:
Single Audit Program – Quality Management System Audit Reports (GD211)

GD211 – Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma

GD211 – Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma (French audio-only)

GD211 – Module 2 – Information about the Manufacturer

GD211 – Module 2 – Information about the Manufacturer (French audio-only)

GD211 – Module 3 – Information about the Audit

GD211 – Module 3 – Information about the Audit (French audio-only)

GD211 – Module 4 – Audit Findings

GD211 – Module 4 – Audit Findings (French audio-only)

GD211 – Module 5 – Conclusions

GD211 – Module 5 – Conclusions (French audio-only)

TEST LINK: GD211 Training Course (English)

TEST LINK: GD211 Training Course (French Canadian)

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Future Course Topics

  • Advanced Quality Systems: Corrective and Preventive Actions
  • Imports
  • Premarket Approvals
  • Home Healthcare

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