US RAC Exam – How to Prepare Most Effectively

Course “US RAC Exam – How to Prepare Most Effectively” has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.


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.

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.

Areas Covered in the Session :

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


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

Who Will Benefit:

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

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance