Scenario Questions

Below are a list of scenario questions with example answers and approaches. My view on structuring a scenario answer is slightly different to what you might have hear when the training bodies out there propose.

This list is small….. it will grow.

• Active Substance Solvent Change

• Draw me a cleanroom

• CFUs present at filling

• Sterility test failure.

• Introduction of a new sterile product

• Non sterile excipient contamination.

• Rogue tablet reported

• WFI Loop Loss of Control

Scenario Approach

My personal experience is that a QP candidate needs to articulate that they understand two things up front:

1) Patient risk

2) What question to ask next

A more formal structured approach to answer the question can follow later in a scenario question answer, but in the first 30 seconds your mind needs to ‘snap’ immediately to articulate what are your concerns w.r.t patient risk and then get a handle on what information you need to come to a more informed view. Only then can you start to think about external communication in terms of contacting anyone outside the organisation.

One of the earliest lessons all pilots learn in flight training is the aviation order of operations: Aviate, Navigate, Communicate. In priority order, you should: fly the airplane (Aviate), figure out where you are and where you're heading (Navigate), and, as appropriate, talk to ATC or someone outside the airplane (Communicate). (From “Setting Priorities” by James Williams)

Have a scenario you want to put forward? Something I have missed? Please contact me.