Seminar on FDA inspections - an Inspectional Lifecycle Approach

Top Quote Atlas Systems is going to organize a seminar titled "FDA inspections - How to Prepare, Manage and Respond - an Inspectional Lifecycle Approach" on October 22nd - 23rd 2015. End Quote
  • Boston, MA-NH (1888PressRelease) September 16, 2015 - This two-day seminar will prepare firms to better manage an FDA inspection and designing/implementing a corrective action plan if FDA threatens to take punitive action against them.

    This course begins with a high level discussion addressing the legal/regulatory basis for an FDA inspections and types of FDA inspections (understand why FDA is there) and the sanctions available to FDA for those companies who choose not to comply with FDA requirements. Next, we cover what to expect during the inspection, including how to communicate with the investigators, run your front and back rooms, and present documents and records.

    Learning Objectives:
    Which FDA sanctions apply to you, and how to operate in compliance with FDA
    What to do when FDA knocks?
    How to handle day by day inspection scenarios?
    What is a front room and back room?
    What are Runners and Scribes?
    Are your SME's the right people, and are they ready/right for the job?
    Why responses and associated corrective action plans to 483's?
    Steps for responding to 483's and Warning Letters.

    Registration Link:
    Emailid : puneet.jha at atlassystems dot com
    Contact No.: +1-609 256 4556

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