Unique BIMO inspection training

Lemon & Lime, a spin-off from Lyncoclinical and Jacobs consulting, worked out a unique hands-on inspection training. Our training is a combination of a theoretical frame illustrated with the real world experience. Several colleagues from the medical devices industry have been trained by us in the meantime. 

DURATION:

3 hour training: 2 slots of 90 min divided by a short break

CONTENT:

Participants will be introduced in a unique way to the specific aspects of a BioResearch Monitoring Inspection (BIMO) FDA inspection.

In 4 steps they will be guided through the inspection journey:

(1)Step 1: Mid-long term preparation

Starting from identifying studies that are at risk for such an inspection to sites at risk.  Participants will familiarize themselves with what they can do during study set-up phase and study conduct to facilitate potential inspections. 

They will learn to reflect on their current behaviors and contributions in quality processes.

The trainers will share after a theoretical frame their experience which will enable the participants to already take home some messages for immediate action even without an inspection announced

(2)Step 2: Short term preparation

From receipt of the inspection announcement to the day the inspector steps in the door.  The time the FDA is announcing before the inspection is different per region. 

The training will more in depth focus on the European region and US as inspection scope.

This phase is crucial if a study team wants to successfully conclude an inspection.  Staying in control of the inspection preparation work while involving all stakeholders requires top level project management, negotiation skills.  But also a lot of common sense and pragmatic solutions. 

This part of the training will focus on the theoretical frame of setting up a functional back office and determining who will act in the front office.  The pro/con’s of a Mock inspection are addressed as well the required administrative/logistic coordinators that are needed.

(3)Step 3: The inspection phase itself

The participants will learn that this phase is in particular a phase of high stress.  As an inspection can last from a few days to a few weeks, stress management and coping strategies are important.

This part of the training will further give the participants insights on communication skills for the front office colleagues and how to interact with the back office.

They will learn how to bring a message or a question to the back office while in parallel managing the inspection progress with the inspector.

(4)Step 4: After the inspection

No 483 or if a 483: the inspection will leave the team with a cold turkey. Participants will be introduced to the follow-up of an inspection. 

The work regulatory and/or the quality department will handle with the support from the clinical operational department.  They will also learn how to take up again the normal day-to-day work the studies require and how to set the pace again for some time lost during an inspection.

Our journey is a combination of a theoretical frame illustrated with the real world experience.  Participants will learn how crucial it is to make the right decisions at the correct timings and how to involve all stakeholders concerned.  They will be receive tips & tricks how to behave, interact and work as a team towards the outcome of not receiving a finding, a 483 or any warning.