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Regulatory Affairs Certificate Program

The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.

As you take on new roles and increased responsibilities, you cannot afford to let gaps in your knowledge base keep you from advancing in your career. With three program options, the curricula are designed to flex to suit your educational needs and goals. These exclusive certificates are achieved by completing a series of customizable online courses, with an emphasis on medical devices and/or pharmaceuticals.

Already have a Regulatory Affairs Certificate in Medical Devices or Pharmaceuticals?
Upgrade to the Dual Certificate and continue to enhance your regulatory knowledge. You can complete the remaining two core courses of the Dual Certificate not provided as part of your original program and three additional three electives to receive recognition of satisfactory achievement of the Dual Certificate.

What is the difference between a certificate and certification?

There may be some confusion about what a certificate program is and is not. The word "certificate" is used broadly as a document awarded to designate the attainment or completion of something. An individual might receive a certificate from an education or training provider as verification of attendance or participation in a learning event (often called a certificate of attendance or certificate of participation). The distribution of a certificate, however, does not indicate that the education or training program completed was a "certificate program." In a certificate program, an individual participates in a learning event or series of events designed to assist him or her in achieving specified learning outcomes within a defined scope, and the individual receives a certificate only after verification of successful completion of all program requirements (including but not limited to an evaluation of learner attainment of intended learning outcomes). If you are having a hard time envisioning what a certificate program is, think of the many certificate programs currently offered by colleges and universities.

It is also important to distinguish certificate programs from the certification of individuals. A professional certification, which may also be called a professional credential requires that an organization grants a credential to an individual after verifying that he or she has met established criteria for proficiency or competency, usually through an eligibility application and assessment. While certification eligibility criteria may specify a certain type or amount of education or training, the learning event(s) are not typically provided by the certifying body. Instead, the certifying body, through an application process, verifies education, training, and experience obtained elsewhere and administers a standardized test of current proficiency or competency. Development of a professional certification or credential takes several years of work involving subject matter experts and experts in testing and measurement. There are strict requirements and standards for credentialing organizations to follow in developing and managing these programs.

In contrast, in a certificate program, the learning event(s) and the assessment(s) are both developed and administered by the certificate issuer, and there is an essential link between them. That is, the learning event(s) are designed to help participants achieve learning outcomes and the assessment is designed to evaluate the learners' attainment of those intended learning outcomes.

Also, certifications have ongoing requirements for maintaining proficiency or competency and can be revoked for not meeting these ongoing requirements. In contrast, certificates do not have ongoing maintenance or renewal requirements and, therefore, cannot be revoked.

Both certification and certificate programs may issue designations and associated acronyms; however, there is no designation or credential associated with completion of a RAPS Certificate program.

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