Conferences / Meetings

Event Categories:

  • search by keywords:

Sponsored Links


  • Managing FDA Inspections from Readiness through Follow up
    Responses: One and a Half day In-Person Seminar

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Apr 24, 2014 08:30 AM
  • End Time:
  • Friday - Apr 25, 2014 01:00 PM
  • Location:
  • San francisco,
    California, United States
  • Course Description:
    If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections:

    -Has your company ever been unprepared for an FDA inspection?
    -How should one respond to a 483 or warning letter correctly the first time without hiring a costly law firm?
    -What the agency can and cannot ask for during an inspection?

    Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.

    Learning Objectives:
    This course on managing FDA inspection will:

    -Define the steps necessary to prepare for an FDA inspection
    -Discuss details surrounding the management of inspections from announcement to close out meeting
    -Offer responses to FAQs regarding typical inspector requests during inspections
    -Define the methodology for responding to 483 and warning letters
    -Offer templates for response letters
    -Discuss common pitfalls to avoid during an inspection

    Who will Benefit:
    This course will provide valuable assistance and guidance to all regulated companies (pharmaceutical, biopharmaceutical, biologics, medical device etc) that are preparing for FDA inspections. The following job titles/ positions will benefit from attending this seminar:

    -Internal Auditors
    -Legal Departments
    -Compliance Officers
    -Validation Managers
    -QC Managers
    -QA Managers
    -Facilities and Engineering Department Staff
    -Compliance Consultants
    -Senior Management
  • Website:
  • Visit the website for detail info


No Comments available

© 2009-2020, All Rights Reserved.
Higher Ed Space ® is a registered trademark of AmeriCareers LLC.