FDA investigations 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-away 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 FDA 483 letter, a warning letter, or a Consent Decree, all of which will impact revenue loss & 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 first-hand of his experience and how his company survived the ordeal.
Areas Covered in this Webinar
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
Learn how a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business.
Who Will Benefit
Quality Affairs Personnel
Regulatory Affairs Personnel
General Counsel/Legal Professionals
Supply Chain Professionals
Drew Barnholtz serves as outside general counsel and compliance officer for durable medical equipment companies, skilled nursing facilities, hospice providers, home health providers, physician practice groups, and start-up businesses. Drew has served as a compliance officer for numerous health care organizations, and has firsthand experience assisting organizations in responding to government investigations. Drew also advises clients on commercial transactions, acquisitions/divestitures, compliance, licensure, bond financing, and a variety of agreements.