US FDA Quality System Regulation (QSR) – What Executives & Senior Managers Must Know

Pre-Recorded CD Webinar
Approximately 90 minutes in length, Self Examination and Answer Key Included

Who Will Benefit
This training solution is essential for the executive and senior management team of your Medical Device Company.

With job functions:
This training solution provides a specific review of the requirements of the US FDA QSR that the executive and senior managers of every department need to know.

Course Description
FDA expects that the executive and senior management team understand their responsibilities as set by the QSR. This training solution provides an effective and cost effective way to provide such training.

This Webinar provides an overview of the requirements of all Subparts of the QSR with specific emphasis on the responsibilities of executive and senior management.

Purchase to own and make this training tool an important component of your training program.

Learning Objectives
After watching this interactive Webinar, you will understand the answers to the following questions:

  • What is the Quality System Regulation and why do I need to understand its requirements?
  • What is a “quality system” and what role do I play in it as a member of executive or senior management?
  • What are each of the QSR Subparts and how do each of them affect my team’s everyday actions?
  • What specific responsibilities do executive and senior management have as set by the QSR and what is the potential impact to the organization if these responsibilities are not fulfilled?
  • What personal culpability do I have as a member of the executive or senior management team
  • What is the most common violative condition cited by FDA in Warning Letters and how does our organization avoid such enforcement action?

Order On-Line to Own This CD Webinar: $195.00