Inspection Readiness

Health Authorities across the globe conducts their field inspections under a strict guidance issued by their corresponding administrative bodies. Importantly USFDA operates under ‘Investigations Operations Manual (IOM)’, which guides and directs all fundamental field activities. FDA investigators are not only experts on subject matter but also well trained to assess individual’s capabilities and integrity through an excellent behavioral analysis. When Investigators arrive at a facility to conduct an inspection, they can easily draw conclusions from what the firm’s employee(s) say and do not say. The best way to ensure investigator’s conclusions reflect positively on your business is to prepare the team for their moment to face an investigator and it requires a lot of coaching and practice.

Our proprietary training for ‘inspection Readiness’ is based on hundreds of agency investigations our team members have hosted in their professional careers and the regulators themselves, who have either conducted inspections or part of a decision making team to decide the outcome of an inspection. We identify the strength and weakness of your team members, through a robust mock exercise and behavioral analysis process based on several factors, like:

a. Competency to comprehend the situation and investigator’s questions
b. Stress management
c. Body language and attitude
d. Tenure of the team member
Reach-out to us for a session and you will see why we are different from others in conducting specialized
learning program based on real time scenarios.