| 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? |