John Robinson
July 10 - 11, 2014 - Boston CA USGlobalCompliancePanel
support@globalcompliancepanel.com
Phone:8004259407
Fax:302-288-6884
Overview: FDA inspections are typically the starting point for the sequence of enforcement actions, since serious violations discovered at inspections will often result in Warning Letters, which in turn, if not properly responded to, can turn into seizures, injunctions, prosecutions, or recalls or consent decrees. So you can look at the number of inspections as one indicator of how aggressive FDA is being regarding enforcement. The seminar will provide an in-depth overview of the various enforcement actions, with primary focus an emphasis on Warning Letters, Seizures, Injunctions and Prosecutions. However, this seminar address as part of a high-level snapshot a multitude of enforcement actions, including 483/EIR enforcement actions, but not limited to: • Application Actions • Certification Withholding or Revocation • Citation • Civil Penalty • Disqualification • Demand for Destruction • Emergency Permit Disapproved • Injunction • License Action (Denial, Suspension, Revocation) • Prosecution • Recall • Remove from Shippers' List • Seizure/Detention We will address FDA enforcement stats in this space with some regularity, trying to discern patterns and trends as related to current state vs. future state. We will address the critical approach necessary to develop a quality remediation plan for inspectional observations (e.g., FDA Form 483/Warning Letter) submitted by FDA. We will examine the importance of having a detailed understanding of the observations and their impact on all quality sub-systems. Management will need to ensure a clear and scientific strategy is developed and communicated to FDA. This is critical to re-establish credibility with FDA and, hopefully, prevent an escalation to a Warning Letter or injunction (i.e., Consent Decree). There are also important technical writing and formatting rules that should be followed when writing one's response. Inadvisable response strategies and deficient remediation efforts will be discussed. Ultimately, the hard work in developing a quality remediation plan will help ensure FDA does not proceed to enforcement actions such as a Warning Letter or worse.