|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 Quality Systems Requirements, 21 CFR 820
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
Implementing a quality system for medical devices can be a complex process. This model will help you to assimilate all of the required knowledge necessary to implement a quality system in accordance with the 21 CFR 820 regulations. Course objectives are: To identify what documentation is required for quality system, to explain the role of key stakeholders in maintaining and establishing a quality system, to identify the requirements of the quality system, and to state how 21 CFR 820 relates to the medical device industry. The course includes an introduction and topics such as production assurance, responsibilities and roles, quality systems, FDA inspection, product documentation, quality assurance, and a conclusion that summarizes the previously listed 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
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 Quality Systems Requirements, 21 CFR 820 course is found in the following professional certification program(s):
ROLES AND RESPONSIBILITIES
State how 21 CFR 820 relates to the medical device industry.
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.