This is at the heart of what it means to be proactive and the catalyst for operational excellence initiatives Both of these lead to increased stakeholder trust.

I hope we get a chance to learn from what happened.

How this is done can often lead to a duplication of effort and resources all of which contribute to waste At the same time, this can and often leads to separate systems each with their own procedures, practices

Changes in job responsibilities, loss of key personnel, and even changes in shift hours can lead to serious These impacts can introduce new risks and expose latent ones leaving companies at risk and vulnerable

previous position no longer exists or has been redefined) Job transfer (permanent, temporary/acting) Leaving participants Enter this information into the OMOC tracking system and operational risk registers To learn

Changes made during the product life-cycle can lead to re-validation and conducting more clinical trials