If you do not manage FDA inspections intelligently, you may get slammed into a regulatory disaster that costs thousands or millions of dollars to fix and months of downtime. Poorly run war rooms can trigger an aggressive shift in how the inspection unfolds. Delays and mindless refusals may seal your fate, and not in a good way. Preparing for the conclusion of the inspection requires careful thought, realistic plans for what to say to the FDA and what you should do to “clean up your act.”
If you do not learn from your FDA violations, the next inspection will dump you into a deeper legal and financial hole due to civil money penalties, seizures, injunctions and prosecutions. Correcting and preventing FDA violations means you must prepare before the FDA shows up. When the FDA finds problems, you will end up relocating resources because you knowingly or unknowingly ignored your problems. You may be required to notify the Securities and Exchange Commission (SEC) due to the adverse financial impact. Preparation and effective learning can salvage your fate.
Join this session with expert speaker Casper E. Uldriks to learn how to implement an inspectional plan before the FDA shows up at your door. You will learn how to manage the inspection itself as it evolves and what you must do to avoid the FDA’s enforcement hammer after your inspection. With this session, you will learn to predict what the FDA will cover during the inspection by using FDA’s own inspectional SOPs and avoid any surprises.
Firms must use effective techniques during the inspection when interacting with the FDA investigator; the session will cover what you should or should not say, dealing with an investigator’s personality and how to answer questions. You will understand how discussions, document collection, daily debriefings and war rooms affect the regulatory outcome of the inspection.
You will learn how to interpret inspectional findings (the 483) not only by the words, but by the format used, and apply it to the FDA’s compliance program evaluation criteria and inspectional classification. You will know with certainty, where you stand with the FDA. You will also learn how to answer the inevitable question that you ask the FDA investigator at the end of the inspection, “So, how bad is it?”
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specializes in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He...
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