Regulatory affairs is a critical field that involves ensuring that products and processes meet legal and regulatory requirements. If you are interested in pursuing a career in regulatory affairs, getting certified can help you develop the knowledge and skills you need to succeed. Here are some of the best certification courses in regulatory affairs:
- Regulatory Affairs Certification (RAC) – This is the most widely recognized regulatory affairs certification in the industry. The RAC is offered by the Regulatory Affairs Professionals Society (RAPS) and covers a wide range of topics, including regulations, ethics, and quality systems.
- Certified Quality Auditor (CQA) – This certification is offered by the American Society for Quality (ASQ) and is designed for professionals who want to develop expertise in quality control and quality assurance. The CQA certification covers topics such as auditing techniques, quality systems, and statistical methods.
- Certified Regulatory Compliance Manager (CRCM) – The CRCM certification is offered by the Institute of Certified Bankers and is designed for professionals in the banking and financial services industry. The certification covers topics such as risk management, compliance, and ethics.
- Certified Clinical Research Professional (CCRP) – The CCRP certification is offered by the Society of Clinical Research Associates (SOCRA) and is designed for professionals in the clinical research industry. The certification covers topics such as research regulations, ethics, and data management.
- Certified Medical Device Professional (CMDP) – The CMDP certification is offered by the Regulatory Affairs Professionals Society (RAPS) and is designed for professionals in the medical device industry. The certification covers topics such as product development, risk management, and quality systems.
These are just a few of the best certification courses in regulatory affairs. Each certification offers its own unique set of benefits and can help you develop the skills and knowledge you need to succeed in this field. Before choosing a certification course, it’s important to consider your career goals and choose a course that aligns with your interests and aspirations.
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What is the RAC?
Regulatory Affairs Certification (RAC) is the leading post-academic professional credential for regulatory professionals in the healthcare product sector. It is intended for individuals employed in regulatory agencies, industry, consultancies and other settings involved with the regulation of healthcare products. Regulatory Affairs Certification tests expertise in two sectors, pharmaceuticals and medical devices, and candidates may choose whether to take the RAC Drugs exam or the RAC Devices exam. All candidates who pass an RAC exam will be equally recognized by the RAC program and will be eligible to put ‘RAC’ after their name.
RAC Examination Overview
- There are two different RAC exams: RAC Drugs and RAC Devices.
- Each examination is based on a survey of the scope of practice and specific roles and responsibilities of regulatory professionals in the workplace with at least three years of regulatory experience. Each examination is reviewed and revised annually, and content is updated for the Summer cycle.
- Exam content for RAC exams is based on regulations and guidelines in effect on December 31 of the year prior. So, exams taken in Summer 2022 will be based on regulations ‘on the books’ on December 31, 2021. For the RAC Devices exam, this includes both MDD and MDR.
- Each examination consists of 100 multiple choice questions to be answered in a two-hour period. Additional time may be allowed for candidates who have requested and received special accommodations. To request special accommodations, please complete the appropriate form in the Appendix of the RAC Candidate Guide.
- The RAC exams are computer-based and administered only at testing centers selected and confirmed by the testing vendor. NOTE: RAC examinations will not be offered at facilities that are not pre-selected and qualified for security measures.
- There are three question formats which may be used in the RAC exams: