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 $895.00
Document a dedication to your career and job performance by earning a professional certification from Biopharma Institute.Training Provided By: Biopharma Institute
This certification program supplies an excellent introduction to the key points in maintaining a quality management system (QMS). Course objectives include training how to recognize the importance of measuring performance, illustrating how the internal audit affects the management role in the QMS, describing the elements of a quality audit program, conveying the responsibilities of quality management roles, and listing the key characteristics of a QMS.
The program goes on to describe record keeping requirements, their controls, and maintenance of medical device documentation. Furthermore, the program dives into the details of a corrective and preventive action (CAPA) system; providing a description of how to identify existing problems, correct them, and execute controls that will help to prevent possible problems. The program continues to describe the essentials necessary to assure an efficient quality management process, safe products, and continued customer satisfaction.
The student will be introduced to medical device records, requirements, and their documentation, as well as their controls. The enrollee will also be educated as to the control, implementation, and development of how records and documentation provide the foundation of a Quality Management System. They will understand why compliance with ISO 13485 standards and the FDA CFR 820 QSRs (Quality System Regulations) are necessary. Those taking this course will be educated on the maintenance and requirements involving a QMS (Quality Management System). The following individual courses are included in this online program: An Introduction to the Regulation of Medical Devices; US Quality Systems Requirements, 21 CFR Part 820; CAPA Systems; Documentation and Record Keeping; and Managing a Quality Management System (QMS).
Students can take the final assessment any number of times, as needed, to achieve a passing grade. Once all course requirements have been satisfied, a professional certification has been achieved.
Benefits of Getting Certified at Biopharma Institute
Throughout many of our courses, students will engage in active learning through the use of interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.
The Medical Device Quality Management System (QMS) 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.