How to Most Effectively Prepare for the US RAC Exam

LIVE Online Seminar: How to Most Effectively Prepare for the US RAC Exam

• Date: February 9, 2015 and March 9, 2015
• Time: 11:00 AM PST | 02:00 PM EST
• Duration: 90 Minutes

About the Seminar

Having a credential for Regulatory Affairs Certification (RAC) can add a great value to one’s professional experience and achievement. Significant benefits of how to effectively study and prepare for the RAC examination may have been frequently neglected or considered less important, leading to spending a lot more than what is reasonably necessary to pass the exam and in many cases, professionals re-take the exam more than once. 

*: RAC stands for Regulatory Affairs Certification. In this case, it refers to the US RAC examination.  

Understanding what and how to study the relevant subjects is one of the first steps and is considered to be the most effective strategy.  An effective preparation of the RAC examination can save a significant amount of your resources (time, energy and money) and beyond (sometimes, saving some level of embarrassment).

This  seminar is intended to help you effectively prepare for the US RAC examination using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive study and understanding in a Systematic, Integrated Manner.

In this 90-min presentation, the speaker will guide you through the details of the contents for you to study (namely, WHAT and HOW) and grasp so that you can be well-prepared for the RAC exam.  

At the end of the presentation, you should be able to come up with your customized, well-guided, actionable strategy to most effectively prepare for and pass the US RAC examination. 

About the Areas to Be Discussed

• 1st 45 Minutes
  • Overview of the US RAC Exam
  • Subject Areas
  • Applicable Laws and Regulations
  • Areas in Pharmaceuticals
  • Good Laboratory Practice (GLP)
  • Good Clinical Practice (GCP)
  • Good Manufacturing Practices (cGMPs)
  • Investigational New Drug Application (IND)
  • New Drug Application (NDA)
  • FDA Guidance Documents
  • Review of Practice Questions
• 2nd 45 Minutes
  • Subject Areas for Biologics and Medical Devices
  • Applicable Laws and Regulations for Biologics and Medical Devices
  • Biological Products
  • Licensing Biologics 
    General Biological Products Standards
  • Investigational Device Exemption
  • Premarket Notification (510(k))
  • Premarket Approval (PMA)
  • Good Manufacturing Practices (cGMPs) for Medical Devices
  • FDA Guidance Documents
  • Review of Practice Questions

NOTE:  Your attendance of this seminar will save your enormous amount of time, energy and efforts while preparing for your successful RAC examination.  

About the Intended Attendee(s)

• Regulatory Affairs
• Scientists
• Engineers
• Healthcare Professionals
• Consultants
• Anyone interested in the topic