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Home » Medical Device Quality Management: CAPA Systems

Medical Device Quality Management: CAPA Systems (MDQ3)

Certification Training
 
Rated 3.83/5
12 reviews
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.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the Biopharma Institute for more information.

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: Medical Device Quality Management: CAPA Systems
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using 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.


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.

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.

The Medical Device Quality Management: CAPA Systems Course is Included in the Following Professional Certification Programs:


Medical Device Quality Management System (QMS) Professional Certification Program: 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 ... 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.

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