Medical Device Quality Management: CAPA Systems (MDQ3)
 | Length of Course: Approximate time to complete this course is 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 
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 Training Program: Medical Device Quality Management: CAPA SystemsTraining Provided By: BioPharma Institute Website: https://www.biopharmainstitute.com Availability: Immediately available upon ordering. Description: Online training with immediate access upon enrollment.  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 satisfaction. This course introduces the student to the requirements of a corrective and preventive action (CAPA) system. Course objectives are as follows: To describe the escalation process and tracking in a CAPA system, to explain the importance of investigation and risk assessment and the critical elements of a CAPA system, to list the various processes and phases of the successful CAPA system, and to identify the regulatory requirements for a CAPA system. The course includes an introduction and covers topics such as elements of successful CAPA systems, the CAPA system, regulations, escalation and tracking, and a conclusion that summarizes all of 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. Over two decades, the BioPharma Institute has compiled a comprehensive offering of learning tools such as books, recorded seminars, live seminars, and online courses. These tools are used to instruct the many aspects of specific applications and job functions found within the healthcare, biotech, and pharmaceutical industries. Have Questions? Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information. 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: CAPA Systems course is found in the following professional certification program(s):
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COURSE OUTLINE:INTRODUCTION 1. Welcome 2. Introduction 3. Overview 4. Key areas of the QMS 5. Reviews and assessments REGULATIONS 6. Overview 7. Compliant CAPA systems 8. FDA QSIT inspections 9. Important definitions 10. Examples of different CAPAs 11. Topic review THE CAPA SYSTEM 12. Overview 13. Features of a CAPA system 14. CAPA flowchart 15. Phases of a CAPA system 16. Topic review ELEMENTS OF SUCCESSFUL CAPA SYSTEMS 17. Overview 18. CAPA system inputs 19. Risk assessment and CAPA 20. Risk assessment process 21. CAPA documentation 22. The CAPA procedure 23. CAPA request/record 24. Correction/containment 25. Investigation & analysis 26. Corrective action 27. Preventive action 28. Verification and closeout 29. Completed CAPA report 30. Topic review TRACKING AND ESCALATION 31. Overview 32. Progress tracking and escalation 33. CAPA trending 34. Topic review CONCLUSION 35. Summary | COURSE OBJECTIVES:--Identify the regulatory requirements for a CAPA system. --List the various phases and the processes of a successful CAPA system. --Explain the critical elements of a CAPA system. --Explain the importance of risk assessment and investigation. --Describe tracking and escalation processes in a CAPA system. | |
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.
