Training and Continuing Education
ORA U Course Catalog 2013 - COMPLIANCE
Course ID: CP207
Course Title: Compliance Law
This course is a review of the FD&C Act, and the new statutory obligations, amendments and updates, and 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 will be able to:
Primary Audience: Compliance Officers and Directors of 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 Centers and Office of General Counsel, advocating with FDA headquarters to take actions, convening PACs, assembling case information for legal actions, and finding and securing expert witnesses). Secondary target audience nominees should give a brief detail how they perform 25% or more of Compliance-specific work.
Prerequisites: Nominees must meet the following pre-requisite:
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