Duration: 2 hours, Online (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 $199.00
Training Program: Medical Device Quality Management: Documentation and Records
Training Provided By: BioPharma Institute
Availability: Immediately available 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 >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.
The Medical Device Quality Management: Documentation and Records course is found in the following professional certification program(s):
2. course Objectives
3. Reviews and Assessments
QUALITY SYSTEM DOCUMENTATION
5. Types of Documentation
6. Scope and Complexity of Documentation
7. Documentation Hierarchy
8. ISO/QSR Documentation Requirements
9. Quality Policy & Objectives
10. Quality Manual
11. SOPs for QS Elements
12. SOPs for Measurement, Analysis and Improvement
13. Design Control Procedures
14. Typical Structure of SOPs
15. QMS Records
17. Topic Review
18. Production Control Documentation
19. Device Master Record
20. Location of DMRs
21. Device History Records
22. Topic Review
DOCUMENTATION AND RECORD CHANGE CONTROL
24. Regulatory Requirements: Document Control
25. A Document Control System
26. Change Procedure
27. Record Control
28. Topic Review
--List the objectives of thorough quality system documentation.
--Explain the elements of quality system documentation requirements.
--Discuss the requirements of a Device Master Record.
--Discuss the requirements of a Device History File.
--List the regulatory requirements for documentation.
--Describe record and change control procedures.
All Courses in the Medical Devices Catalog:
|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: This is an online program offering training with immediate access upon enrollment. Medical devices are globally regulated by a series of regulations and rules designed to produce an effective and safe device. T ... 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|
|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 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 180 days for professional certification programs
- Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Purchase orders (POs) accepted: If POs are required, 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 offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization
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.