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: CAPA Systems
Training Provided By: BioPharma Institute
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.
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):
4. Key areas of the QMS
5. Reviews and assessments
7. Compliant CAPA systems
8. FDA QSIT inspections
9. Important definitions
10. Examples of different CAPAs
11. Topic review
THE CAPA SYSTEM
13. Features of a CAPA system
14. CAPA flowchart
15. Phases of a CAPA system
16. Topic review
ELEMENTS OF SUCCESSFUL CAPA SYSTEMS
18. CAPA system inputs
19. Risk assessment and CAPA
20. Risk assessment process
21. CAPA documentation
22. The CAPA procedure
23. CAPA request/record
25. Investigation & analysis
26. Corrective action
27. Preventive action
28. Verification and closeout
29. Completed CAPA report
30. Topic review
TRACKING AND ESCALATION
32. Progress tracking and escalation
33. CAPA trending
34. Topic review
--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.
Online Training Program Benefits:
- 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.