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  • How to Address and Remediate FDA 483's, Warning Letters and
    Consent Decree Issues

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Apr 30, 2013 10:00 AM
  • End Time:
  • Tuesday - Apr 30, 2013 11:00 AM
  • Location:
  • Online
  • This webinar will describe the steps to remediation of compliance issues associated with FDA 483s, Warning Letter and Consent Decree issues. It will discuss the Do's and Don'ts when you receive an FDA 483 citation, Warning Letter or Consent Decree.

    Why Should You Attend:

    The criticality of the Code of Federal Regulations (CFR) regulations and guidelines cannot be over emphasized hence this course will make participants aware about the stages of compliance related issues and resulting impact to the manufacturer of a FDA regulated product.

    The session will help participants relate to the implications of not adhering to the rules and regulations which on numerous occasion has led to the closure of a manufacturing site through an FDA injunction and further bankruptcy of a cGMP product manufacturer. Understanding the cost implications that are associated with remediation of an FDA consent decree is very high and most manufacturers of a cGMP drug product have found it very difficult to come out of a consent decree due to the difficulties associated with remediation.

    This presentation will show how you can act expeditiously to resolve any of the compliance related issues before they get out of hand and impact the livelihood of employees.
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