Course Title: Compliance Law
This course is a review of the Food, Drug and Cosmetic Act (FD&C Act) and the new statutory obligations, amendments and updates, as well as general discussions regarding court versus administrative actions. Case studies will reinforce the principles and concepts taught in the lecture. This is a dynamic learning experience designed to build upon the knowledge and experience of the participants.
Upon completion of the course, participants should be able to:
- Recognize and differentiate between foods, drugs, biologics, devices, radiological products, cosmetics, and tobacco products under the statute.
Explain the FD&C Act’s statutory structure and elements necessary to support legal actions.
Determine which enforcement actions are appropriate in different situations from a theoretical and practical standpoint.
Utilize statutory requirements for adulteration and misbranding charges relating to FDA-regulated commodities.
Apply elements of proof supported by evidence from establishment inspections, sample collections, and laboratory analyses, permitted by statutory authorities of the FD&C Act.
Identify historical and recent major legislative changes to statutes enforced by FDA.
Analyze the statutory foundation for prohibited acts, legal actions, and criteria for assessing responsibility.
Recognize the role of FDA enforcement policy and practical considerations when selecting appropriate regulatory options.
Explain precedent court decisions that affect FDA actions.
Describe the lawsuit process in the federal court system.
Recognize applicable federal rules which apply to seizures and injunctions.
Identify FDA’s authority to review imported FDA-regulated products, in conjunction with Customs and Border Protection (CBP).
Primary Audience: Compliance Officers and Compliance Branch Directors (DCBs)
Secondary Audience: Professionals who perform 25% or more of Compliance-specific work and/or make compliance decisions (such as reviewing EIRs for enforcement, reviewing laboratory evidence, drafting recommendations for enforcement actions, recognizing potential enforcement actions, making regulatory decisions, coordinating actions with the Centers and Office of Chief Counsel (OCC), advocating with FDA headquarters to take actions, convening PACs, assembling case information for legal actions, finding and securing expert witnesses). A one paragraph rationale must be submitted identifying performance of Compliance-specific work and/or compliance decisions.
Prerequisites: Prior to attending, nominees must:
Complete the ORA New Hire training curriculum (FDA: Level I including the audit), or completed the six (6) month district training program (includes 3 week ORA New Hire training curriculum), if hired prior to January 1, 2002 and not Level I; State employees must have completed their new hire program and have experience working in the program area.
Currently be in, or assigned to a position involving the review of information (inspections and analytical work) received from Inspections Branch (IB) and processing of enforcement actions.
Course Duration: 4.5 Days
Course Title: Practical Compliance Applications
Course Description: This course is designed for Directors of Compliance Branch (DCB) and Compliance Officers (CO) who perform compliance work. Students will be taught the “practical applications” of preparing and processing seizures and injunction actions. This course is designed in two parts. The first part will focus on the decision making process involved in selecting an appropriate course of action. The second part of the course will focus on providing the practical, hands-on experience of processing seizure and injunction actions, including but not limited to: preparation, monitoring, and trial/post-trial activities. The instructional strategies used in the course include lectures, demonstrations, “hands-on” exercises and case studies. Students are expected to prepare seizure and injunction case initiation memos and legal documents.
Upon completion of the course, the participant should be able to:
- Identify evidence (e.g., lab analysis report, memos, EIRs, etc.) used to support a seizure and/or injunction.
- Describe the process of using SARA (selecting appropriate regulatory actions) in proceeding with a seizure and/or injunction.
- Identify the steps in preparing and processing seizure actions.
- Identify the steps in preparing and processing injunction actions.
- Demonstrate knowledge of concepts previously learned from job experience and formalized training.
Target Audience: The targeted audience includes DCBs and COs who process seizures and injunctions. Priority should be given to compliance officers who are required to process seizure or injunction actions.
Completed their New Hire training curriculum (FDA: Level I, including the audit, or completion of 6 month district training program (includes 3 week new hire program) if hired prior to Jan 1, 2002 and not Level I).
Completed Compliance Law (CP207) training course
Course Duration: 8.5 Days
Course ID: CP213 (formerly IM213)
Course Title: Practical Compliance Applications for Imports
Course Description: This course is designed for compliance officers who review cases related to imported products. It focuses on the decision making process involved in selecting an appropriate course of action and provides hands-on experience in processing Broker Penalties, Civil Money Penalties, and Liquidated Damages. The CP213 course consists of a combination of lectures and classroom exercises.
Upon completion of the course, the participant will be able to:
- Identify legal issues that impact import operations.
- Evaluate evidence to select an appropriate course of action and support an enforcement recommendation.
- Assess and respond to liquidated damage petitions, Civil Money Penalties or Broker Penalties.
- Apply knowledge of Custom and Border Protection operations.
- Use the appropriate Custom and Border Protection (CBP) sanctions in real life situations
Primary:Compliance Branch Directors (DCBs) and Compliance Officers (COs) who review cases related to imported products, and Import Operations Branch Directors (DIOBs)
Secondary: Import Program Managers (IPMs), Supervisory Consumer Safety Officers (SCSOs), and other Compliance Officers who routinely work on cases related to import operations including submitting import related cases into Compliance Management System (CMS), reviewing and endorsing investigative memos and completing import activity quality factor sheets. Secondary target audience nominees should give a paragraph on how they perform 25% or more of the above criteria.
- Access to most commonly used software system applications (CMS, MARCS, OASIS and ORADSS) when making compliance based decisions about imported products.
- Familiarity with the various FDA Center databases when making compliance-based decisions about imported products.
Course Duration: 4.5 Days