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.
A brief summary in form of a checklist will be shared upon request.
Chief Strategic Advisor
Head of Quality Assurance
Our main goal is to collect vast experience and knowledge about early phase clinical trials and share it with a broad international audience.
Our seminars are dedicated to professionals with a broad range of experience and lay audience as well. Even if you have years of experience, you will find something interesting, as we would like to focus on sharing the experience of our presenters based on real-life cases.
A discussion with the presenter is foreseen after most panels – please see the agenda.
