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
Who Will Benefit:
- Quality Affairs
- Regulatory Affairs
- General Counsel/Legal
- Supply Chain
Drew Barnholtz serves as an outside general counsel and compliance officer for skilled nursing facilities, hospice providers, home health providers, physician practice groups, durable medical equipment companies, pharmaceutical and start-up businesses. Drew has served as a general counsel and compliance officer for numerous health care organizations, and has firsthand experience assisting organizations in responding to government investigations (including serving as the Deputy General Counsel of Invacare Corporation, and the Assistant General Counsel for University Hospitals Health System). Drew also advises clients on commercial transactions, acquisitions & divestitures, compliance, licensure, bond financing, and a variety of agreements.
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Event Link : http://bit.ly/1j8Ha7T
Contact the event managers listed below for more information about how you can participate at the Webinar on How to Respond to an FDA Investigation: What happens when the FDA threatens to shut you.
|Conference/Event Dates:||11/30/2015 - 11/30/2015|
|Primary Industry:||Food / Beverage|
|Other Industries:||Business, Food / Beverage, Law|
|Cost to Attend:||One Dial-in One Attendee Price: US$150.00|
|Booth Size||Booth Cost||Available Amenities|
|Marketing Vehicles Allowed:||n/a|
|Other Booth Sizes Available: n/a|
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