cGMP: Pharmaceutical CAPAs (GMP10)
 | Duration: 2 hours, Online (the average time to complete the training program, including final assessments). Credits Hours: 2Self-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 
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 Training Program: cGMP: Pharmaceutical CAPAsTraining 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. The cGMP: Pharmaceutical CAPAs course is found in the following professional certification program(s):
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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). | |
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
- 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
- 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 may 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.
