Webinar: Are you ready for an FDA inspection?

Inspection readiness program in Early Phase Clinical Trials.

Biokinetica’s team will share an experience on FDA Inspections, and methods how effectively support your organization to be optimally prepared for any announced or unannounced Inspection.

We will focus on Early Phase study Inspections considering the increasing number of Biologic and Biosimilar projects submitted to the FDA for review and approval.

Our Webinar will provide insights how to prepare your team, your documentation, your facilities and the logictics.

We will discuss communication with the Inspector, and behaviours of the team during the Inspection and during interviews, as well as the value of a mock audit.

The Biokinetica team will be happy to entertain any question from the audience, and be available for follow up.