Responding to FDA 483 observations was my focus in part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent recurrence of the underlying problem that led to the observation.

Here, I’ll share my views on getting the work done to fulfill commitments made to the FDA. The following have become benchmarks from those who are the best at getting the job done and getting the problems behind them:

Form teams
This might seem obvious, but forming cross-functional teams representing stakeholders is often overlooked. The solution will likely involve different ways of working those cross-functional lines. It’s a rookie mistake to think that the fix is something for the quality department to do on its own, or just an editorial change to a procedure. Depending on the problem, the team may need to be dedicated to the project to allow focus, particularly if accelerated timelines are involved. Include subject-matter experts who have the scientific, technical, and cGMP backgrounds to provide appropriate guidance.

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