1 August – 28 September 2018
The RAC (US) Prep Virtual Program provides a thorough knowledge of regulatory functions throughout product lifecycle for medical devices, IVDs, pharmaceuticals and biologics. Using the Fundamentals of US Regulatory Affairs book as a foundation, the program provides real-world examples and practical applications provided by regulatory experts. It also includes information about FDA regulations and employs critical thinking and analytical skills to help you better prepare for the RAC (US) exam.
The assigned readings and on-demand webcasts follow the 9th edition of the Fundamentals of US Regulatory Affairs, not the recently-released 10th edition. However, the program resources include a reference sheet to find the same content in the 10th edition.*
This virtual format offers a more flexible schedule, so you can take notes and review topics at your own pace. The program includes six live Q&A sessions with regulatory experts who can provide more clarity and answer your specific questions. Dig into and revisit topic areas you need more time on, or use familiar information as a reference to brush up on your regulatory knowledge.
The following topic areas are covered:
- General information
- Medical devices
- Other product classifications
- Inspection and enforcement
This is a high-engagement program with different learning and study formats including:
You will have access to the content starting Wednesday, 25 July.
- Eight weeks of lessons in a virtual classroom setting through on-demand webcasts and reading assignments
- Six live, expert-led Q&A sessions
- Expert regulatory facilitators
- Online community for virtual study groups
- RAC (US) practice exam
- Study checklist
- US exam content outline
*Fundamentals of US Regulatory Affairs is not included with your registration.