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Sunday, December 16, 2018
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cGMP: Pharmaceutical CAPAs (GMP10)

Certification Training Duration: 2 hours (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: Good Manufacturing Practices (GMP).
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

BioPharma Institute LogoTraining Program: cGMP: Pharmaceutical CAPAs
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This online training program describes corrective and preventive actions (CAPAs), and how good manufacturing practices can be applied to eliminate causes of non-conformities or other undesirable situations. The training program enables the students to interpret and identify the requirements of a pharmaceutical CAPA system. As a fundamental management tool, CAPA is integral to the effectiveness of a quality management system. The objectives of this course are to teach the requirements of ICH Q10- PQS (Pharmaceutical Quality System), describe escalation and tracking processes in a CAPA system, explain the importance of investigation and risk assessment, list a CAPA system’s critical elements, explore the different processes and phases of a good CAPA system, and identify a CAPA system’s regulatory requirements. Once all course requirements have been satisfied, a certificate of completion will be immediately available via PDF.

Benefits of Getting Certified at BioPharma Institute

BioPharma Institute is an online training institute for professionals with careers in the pharmaceutical, biotechnology, clinical research, and healthcare industries. For over two decades we have assisted thousands of businesses in the successful training of their employees. In addition to our certifications being recognized by those in a wide spectrum of industries, we have customizable training solutions that can meet the needs of any organization, no matter how big or small.

With state-of-the-art e-learning techniques that simplify the education process, we provide various educational tools to assist our students in learning the essentials. Whether training new employees or offering a refresher course, the BioPharma Institute has the knowledge and industry resources needed in order to deliver the best training possible for you, your colleagues, and your employees.

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.

Online Training Programs Include:

  • Immediate access to training: Instructions, user name, 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 training: 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
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The cGMP: Pharmaceutical CAPAs course is found in the following professional certification program(s):


Current Good Manufacturing Practice (cGMP) Professional Certification Program: The Good Manufacturing Practice (GMP) Professional Certification Program is a comprehensive overview on the best practices regarding control and management of manufacturing and quality control testing for pharm … Learn more


COURSE OUTLINE:


INTRODUCTION
1. Welcome
2. Introduction
3. Overview
4. Pharmaceutical Quality System (PQS) Model
5. Key areas of the QMS
6. Reviews and assessments

REGULATIONS
7. Overview
8. Compliant CAPA systems
9. Activity: Looking for CAPA requirements within GMPs
10. FDA QSIT inspections of CAPA systems
11. Important definitions
12. Examples of different CAPAs
13. Topic review

THE CAPA SYSTEM
14. Overview
15. Features of a CAPA system
16. CAPA flowchart
17. Phases of a CAPA system
18. Topic review

ELEMENTS OF CAPA SYSTEMS
19. Overview
20. CAPA system inputs
21. Risk assessment and CAPA
22. Risk assessment process
23. CAPA documentation
24. The CAPA procedure
25. CAPA request/record
26. Correction/containment
27. Corrective action
28. Preventive action
29. Verification and closeout
30. Completed CAPA report
31. Topic review

ROOT CAUSE ANALYSIS
32. Symptom or Root Cause?
33. When to conduct RCA/CAPA
34. Root Cause Analysis (RCA)
35. Investigation & Analysis

TRACKING AND ESCALATION
36. Overview
37. Progress tracking and escalation
38. CAPA trending
39. Topic review

CONCLUSION
40. 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.
Recognize the requirements of ICH Q10 – Pharmaceutical Quality System (PQS).


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.

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