Training and Continuing Education
ORA U Course Catalog 2013 - COMPLIANCE
Course ID: CP207
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:
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:
Course Duration: 4.5 Days
Course ID: CP210
Course Title: Practical Compliance Applications
Course Description: This is a 2 week course designed for directors of compliance branch (DCB) and compliance officers (CO) who perform compliance work. Students will be taught the “practical applications” of selecting and processing seizures and injunctions. 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 will be able to:
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.
|Course Duration: 8.5 Days||CEU: 6.5|
|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.
Course Objectives:Upon completion of the course, the participant will be able to:
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.
| Prerequisite: |
|Course Duration: 4.5 Days||CEU: 3.4|