Medical Device Quality Management: CAPA Systems
|
2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
.
Browse Our Catalog of 300+ Courses:
Catalog of CoursesEnroll into a Trial Course & Start Learning, Today:
Free Trial CoursesOutline: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 | Objectives: | |
Use our Search Form to Find What You're Looking For:
Benefits of Training with Biopharma Institute
Immediate access to courses: | Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment. |
Self-paced, asynchronous eLearning: | 24/7 access to all course materials and assessments for 12 months. |
Open enrollment: | No prior course prerequisites or work experience required. |
Expertise: | Courses developed by subject matter experts (SMEs) in the area being taught. |
Current and validated: | Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited. |
Optimized for learning: | Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter. |
Secure and safe access: | Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance. |
Flexible final assessments: | Multiple-choice questions can be taken repeatedly until a passing score is achieved. |
Direct access to certificates: | Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode. |
Verification of training: | Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs. |
Training manager access: | A proprietary portal offers access to download enrollment reports, training records, account balance, and more. |
SCORM-compliant courses: | Courses can be delivered directly to most corporate Learning Management Systems (LMS). |
Purchase orders (POs): | POs are accepted from all companies. Request an invoice when starting the procurement process. |
Reimbursement: | Some employers may reimburse their employees for training expenses. Check your company's policy. |
Financial assistance: | Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option. |
Career advancement: | Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties. |
Have Questions? Contact Us:
Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.