Online Training 2016 - How to Respond to an FDA Investigation: What happens when the FDA threatens to shut you? - By Compliance Global Inc

Speaker: Drew Barnholtz
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.
Overview
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
Lesson learned
Learning Objectives
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
CEOs
CFOs
Quality Affairs Personnel
Regulatory Affairs Personnel
General Counsel/Legal Professionals
Manufacturing Professionals
Engineering Professionals
Distribution Professionals
Supply Chain Professionals
Level
Beginner
For more detail please click on this below link
https://complianceglobal.us/product/700204/DrewBar...
Email: referrals-AT-complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Super Combo Offer 1
Live and Recorded webinar for $325 only!
Price: $325
Super Combo Offer 2
Live and Training CD for $495 only!
Price: $495
Live Session
for one participant
Price: $155
Corporate Live Session
Group - Max 10 Participants from one Location.(For multiple location please contact our customer support team)
Price: $425
Recorded Session
Get unlimited access to the link for six months. Login information will be shared 24 hours after the completion of Live webinar
Price: $195
Training CD
Free shipment within 72 Hours, from the date of webinar completion
Price: $395