Method of Training: Online / Self-paced eLearning.Credit Hours: 2 credits.
Duration: ~2 hour(s).
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 $199.00
Demonstrate your dedication to job performance by earning a training certification from Biopharma Institute.Training Program: Medical Device Quality Management: Documentation and Records
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment.
Control, implementation, and development of documentation and records provide the foundation of a quality management system (QMS). It also provides the evidence of compliance with the FDA CFR 820 Quality System Regulations (QSRs) and the ISO 13485 standards. This course introduces students to records requirements, their controls, and medical device documentation. The course objectives are to describe the record and change control procedures, to list the regulatory requirements for documentation, to discuss the requirements of a device history file and the device master record, further explain the elements of quality system documentation requirements, and lists the objectives of the role quality system documentation. The course includes an introduction and topics such as documentation and record change control, product-related documentation, quality system documentation, and offers a conclusion that views the previously listed topics. The program also includes progress checks, links to external resources, and a glossary.
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 passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
The Medical Device Quality Management: Documentation and Records Course is Included in the Following Professional Certification Programs:
Full List of Programs in the Medical Devices Catalog:
|Global Medical Device Regulatory Affairs Professional Certification Program: This Global Medical Device Regulatory Affairs Professional Certification Program is an online program which guides the student through a global medical device regulations overview. It discusses how ISO13485:200 ... Learn more|
|US Medical Device Regulatory Affairs Professional Certification Program: 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 ... Learn more|
|Medical Device Quality Management Professional Certification Program: This online certification program supplies an introduction to the requirements of a Corrective and Preventive Action (CAPA) system; provides a description of how to identify existing problems, correct them, and ... Learn more|
|Medical Device Regulatory Affairs: Australian Overview: This online program is an overview of Australian regulatory affairs. The course objectives are to describe the systems of classification for medical devices; define the roles of the regulator, manufacturer, and ... Learn more|
|Medical Device Regulatory Affairs: Australian Requirements for Registration: This is an online program offers training with immediate access upon enrollment. The students will be introduced to the specifics that are required before a medical device is qualified to go to market. The prog ... Learn more|
|Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements: This course details the regulatory expectations for quality management system (QMS) certification, identifies vital elements of the essential and standard administration roles, and explains how ISO 13485:2003 ( ... Learn more|
|Medical Device Regulatory Affairs: Global Risk Management: This online program explains relevant risk management terminology. The course identifies the process of risk management, details all of the documentation required, and discusses how risk can be calculated. Cour ... Learn more|
|Medical Device Quality Management: Managing a QMS: This course teaches the student about the maintenance of a quality management system (QMS). Course objectives include training how to recognize the importance of measuring performance, illustrating how the inte ... Learn more|
|Medical Device Quality Management: Documentation and Records: Control, implementation, and development of documentation and records provide the foundation of a quality management system (QMS). It also provides the evidence of compliance with the FDA CFR 820 Quality System ... Learn more|
|Medical Device Quality Management: CAPA Systems: The ability to correct and identify existing problems and implement controls to prevent potential problems is essential for efficient quality management processes, safety products, and continued customer satisf ... Learn more|
|Medical Device Regulatory Affairs: US Overview: 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 ... Learn more|
|Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820: 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 ... Learn more|
|Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme: This course introduces the student to the required activities necessary before a device is ready to go to market in the United States. The US Regulatory Affairs Overview (MDU1) course is recommended as an intro ... Learn more|
|Australian Medical Device Regulatory Affairs Professional Certification Program: The Australian Medical Device Regulatory Affairs Professional Certification Program will introduce to students the activities that are required before a medical device is ready to go to the Australian market.Th ... Learn more|
|An Introduction to the Regulation of Medical Devices: This program provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA.
We explain what me ... Learn more|
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