Overview:
An FDA investigation can lead to observations requiring remediation, disruption of your business, loss of revenue and enforcement actions up to and including having your plant shutdown. Come learn from someone who’s “been there and done that” having gone through an intense FDA investigation with a global manufacturer of durable medical equipment that resulted in the imposition of a Consent Decree and plant shutdown. Take-aways will include practical tips on how to interact with the FDA and create sustainable corrective actions.

Why should you attend: How would you respond to an FDA investigation? It could be a 483 observation, a warning letter, or a Consent Decree, all of which will impact how you carry on your business while under investigation. Drew Barnholtz has “been there, done that” when it comes to the FDA investigation and Consent Decree process. Learn firsthand of his experience and how his company survived the ordeal.

Areas Covered in the Session:

• What a company should do if the FDA shows up unannounced
• How a company should respond to 483 observations or a warning letter
• The affect an FDA investigation can have on a company
• The basic concepts that should be employed by everyone regulated by the FDA
• How a company can prepare for situations like the this
• Lesson learned
• How a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business