Method of Training: Online / Self-paced eLearning.Credit Hours: See individual courses located below for total credits assigned to this program.
Self-paced Training: 24/7 access to course.
Enrollment Period: 6 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $495.00
Document a dedication to your career and job performance by earning a professional certification from Biopharma Institute.Training Provided By: Biopharma Institute
This online certification program provides an introduction to the Code of Federal Regulations (CFRs). It introduces students to the activities that are essential prior to a device being set to go to the United States market. Additionally, it assimilates the knowledge needed in order to execute a quality system in accordance with the 21 CFR 820 regulations. The following individual courses are included in this online program: An Introduction to the Regulation of Medical Devices; US 501K Premarket Notification Scheme; US Quality Systems Requirements, 21 CFR 820; and US Overview of Medical Device Regulatory Affairs.
Once all course requirements have been satisfied, a professional certification has been achieved. 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
BioPharma Institute utilizes e-learning courses that make it convenient for businesses to educate their employees, allowing for a flexible schedule that doesn't require employees to set aside time to attend live classes. For two decades, we have been offering solutions and online training for thousands of organizations throughout the biotechnology, pharmaceutical, and healthcare industries. We can provide you with the education needed to further your career or refresh your skills.
The US Medical Device Regulatory Affairs Professional Certification Program includes these individual courses:
Online Training: The Benefits of eLearning
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
- Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option
- Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization