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    ONLINE TRAINING 2015 - How to Respond to an FDA Investigation: What happens when the FDA threatens to shut you? - By Compliance Global Inc.

    View: 314

    Website https://complianceglobal.us/product/700204/DrewBarnholtz/respond-to-an-fda-investigation/1 | Want to Edit it Edit Freely

    Category FDA Investigation, fda approval process, fda regulation, fda 483 letters, fda 483, fda rules and regulations, register with fda, FDA Warning letters, FDA threatens, profit and loss statement, revenue loss, profit and loss revenue on income statement

    Deadline: October 13, 2015 | Date: October 13, 2015

    Venue/Country: New Hyde Park, U.S.A

    Updated: 2015-09-07 15:08:23 (GMT+9)

    Call For Papers - CFP

    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/DrewBarnholtz/respond-to-an-fda-investigation/1

    Email: referralsatcomplianceglobal.us

    Toll Free: +1-844-746-4244

    Tel: +1-516-900-5515


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.