2-day In-person Seminar on Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions at Minneapolis


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.

Why should you attend?

• Address different types of Warning Letters
• Understanding FDA's enforcement strategy and what it means to your firm
• Understanding how auditors think and their expectations
• Being prepared to receive regulatory inspections
• Recognizing when inspectional findings or events indicate potential regulatory actions
• When to take or not immediate action during an inspection
• Making better responses to FDA both during and following inspections
• How to make written procedures and training more effective
• How to increase the effectiveness and efficiency of internal audits
• How to identify effective compliance metrics
• Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion as applicable
• Review and discuss pain points, challenges and solutions
• Understand the use of FDA's Administrative Enforcement Tools
• Inspectional Options based on Inspectional Violations
• Current FDA Enforcement Priorities: Application and Data Integrity Policy

Course Outline:
Day 1 – June 5th 2014

Lecture 1: FDA History, Inspection Preparation, Handling and Closure
• How a firm should prepare for an FDA inspection
• Ways to train employees in view of the inspection
• How to ensure that required documentation is in place
• How to interact with the investigator-DO's and DON'T's
• What companies should do when the inspection ends
• How to reply to 483's and warning letters
• Legal implications of non-compliance
• Post inspection actions
Lecture 2: Warning Letters
• Considered an Advisory Action
• A communication to the firm that has been reviewed within several levels of the FDA, including the district office and the Center at FDA's headquarters
• The Warning Letter generally states that the firm has made products that are adulterated, violating the Food, Drug, and Cosmetic Act and that the firm has a very limited amount of time to address the problem(s) before the FDA takes further regulatory action against the firm, the adulterated product, and responsible individuals
Lecture 3: Recap of Day 1

Day 2 – June 6th 2014

Lecture 4: Seizures
• Seizures are approved by a U.S. Federal Court judge; U.S. Marshals accompany the FDA during a seizure
• After seizure, no one may tamper with the goods except by permission of the court
• The court usually gives the owner or claimant of the seized merchandise approximately 30 days to decide a course of action
• General Guidelines for Seizures
• Types of Seizures
• Direct Reference Seizure Authority
• Approval Process for Seizure and Injunction Cases
• Responsibilities for Seizure Actions
Lecture 5: Injunctions
• Adequate Notice Preceding Injunction Actions
• Prerequisites for a TRO or Preliminary Injunction
• Refreshing Evidence - Updating Inspections
• Approval Process for Seizure and Injunction Cases
• Responsibilities for Injunction Actions
• Cover Letter to DOJ
• Complaint for Injunction
• Declarations
• Consent Decree
• Costs of Supervision
• Compliance Follow-Up
• Vacating Injunctions
Lecture 6: Prosecution
• Criminal Prosecution: In some cases, usually involving fraud, FDA and federal prosecutors will file criminal charges against an individual. If found guilty, the person is subject to fines and prison time.
• Punishment in a prosecution and sentencing guidelines and recent examples
• In furtherance of Commissioner Hamburg's call-to-action, FDA has issued special procedures and considerations for "Park" prosecution recommendations now...industry is on notice.
• Communication Between OCI and Other FDA Components
• Processing A Summary And Recommendation
• Criminal Prosecution after Section 305 Notice
• Criminal Prosecution Without Section 305 Notice
Lecture 7: Exercise and Recap of Day 2
• Exercise
• Quiz

Who Will Benefit:

• Individuals who come in contact with regulatory inspectors
• Auditors
• Compliance/Regulatory affairs professionals
• QA/QC professionals
• Senior management executives (CEO, COO, CFO, etc.)
• Manufacturing managers, supervisors & personnel
• Project Managers
• Regulatory Affairs Management
• Regulatory Affairs Specialist
• Auditors
• Compliance Officer
• Compliance Specialist
• Clinical Affairs
• Quality Assurance Management
• Marketing & Sales
• Operations/Manufacturing
• Consultants

About Speaker:

David R. Dills
Regulatory Affairs & Compliance Consultant,

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He has been involved in many FDA and other regulatory inspections as well as part of multiple FDA remediation activities involving CIA's Consent Decrees, Seizures and other enforcement actions, including responding to Warning Letters. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.


Location1: Location: Minneapolis Date: June 5th & 6th 2014 Time: 9 AM to 6 PM CDT

Location2: Location: Boston Date: July 10th & 11th 2014 Time: 9 AM to 6 PM EDT


Price: $1,295.00

Register now and save $200. (Early Bird)
Until April 30, Early Bird Price: $1,295.00
From May 01 to June 03, Regular Price: $1,495.00

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