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  • Coping with a Difficult Compliance Officer when Responding
    to a 483, Warning Letter, Import Alert or Recall

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Friday - Aug 09, 2013 10:00 AM
  • End Time:
  • Friday - Aug 09, 2013 11:00 AM
  • Location:
  • Online
  • This webinar on handling FDA inspectors will discuss practical tips to cope with a difficult FDA compliance officer or inspector. You will learn how to wiggle out of complicated situations, make legal arguments and challenges to the FDA agent and use meeting requests and other tools to ease tensions.

    Why Should You Attend:

    - How do you deal with a difficult compliance officer or recall coordinator?
    - How do you know when to push back, to cry foul, or ask for the district compliance director to be involved?
    - When should you make legal arguments and challenges?

    Inspections by the FDA are perhaps the most intimidating and stressful of all events at a regulated facility. That stress can be amplified exponentially when dealing with a difficult compliance officer or recall coordinator.

    The instructor is an attorney and a veteran with extensive experience in working with both the FDA and USDA on compliance, recalls, and import matters.

    Areas Covered in the Webinar:

    - Outline of FDA enforcement and compliance scheme.
    - FDA inspection process.
    - Lead up to a warning letter - warning signs.
    - Warning letter issuance.
    - Company response to FDA warning letters.
    - When to make legal arguments and challenges
    - How to cry foul to the district compliance officer
    - Meeting requests and other tools to ease tensions
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