|Duration: 1.7 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $169.00
Training Program: Medical Device Regulatory Affairs: US Overview
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
The medical device industry in the USA is governed by a number of important regulations, the most important of those being contained within the CFRs (code of federal regulations) – 21 CFR part 800 series. This course introduces the student to a number of these regulations. Course objectives include a comparison of the characteristics of required regulatory control for each of the various classes of medical devices, a description of the classification system of medical devices, how to locate the medical device regulations pertaining to particular areas of the industry, and a definition of important medical device terminology. The course includes an introduction and topics such as regulatory control and the classification system, an overview of the US regulatory system, and a conclusion summarizing those topics.
Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade.
Benefits of Getting Certified at BioPharma Institute
The BioPharma Institute has worked proudly with thousands of companies in the healthcare, biotechnology, and pharmaceutical industries. By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
Online Training Programs Include:
The Medical Device Regulatory Affairs: US Overview course is found in the following professional certification program(s):
OVERVIEW OF THE USA REGULATORY SYSTEM
CLASSIFICATION SYSTEM AND REGULATORY CONTROL
–Define important medical device terminology.
For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.