NEW inspection training
Lyncoclinical and Jacobs Consulting are developing a unique training concept introducing you to a BioResearch Monitoring Inspection (BIMO) or a (Pharma) FDA inspection.
In 4 steps you will be guided through the inspection journey:
Step 1: Mid-long term preparation
Starting from identifying studies that are at risk for such an inspection to sites at risk. You will familiarize yourself with what you can do during study set-up phase and study conduct to facilitate potential inspections.
Learning to reflect on your behaviors and contributions in quality processes.
We both will share after a theoretical frame our experience which will enable you to already take home some messages for immediate action even without an inspection announced:
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 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.
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.
Step 4: After the inspection
No 483 or if you receive a 483: the inspection will leave you and your team with a cold turkey. We will be introduce you to the follow-up of an inspection. If there is any follow up required from regulatory and/or the quality department: they can only handle this with the support from the clinical operational department. You will also learn how to take up again the normal day-to-day work and how to set the pace again for some time lost during an inspection.
This BimoBitchTM journey will be 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.