cGMP: Pharmaceutical CAPAs (GMP10)
 | 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. Catalog: Good Manufacturing Practices (GMP). Demonstration: Try one of our FREE courses. Certificate: View sample certificate. PRICE: USD $199.00 
|
 Training Program: cGMP: Pharmaceutical CAPAsTraining 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.  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 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. The cGMP: Pharmaceutical CAPAs course is found in the following professional certification program(s):
|
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). | |
All Courses in the Good Manufacturing Practices Catalog:
 | cGMP: An Introduction to Good Manufacturing Practices: This GMP course includes an introduction to current good manufacturing practices (cGMPs), information on maintaining product quality, the scope of GMP rules, a section on cleaning and sanitation, a look into pr ... Learn more |
 | cGMP: Warehouse: The GMP for the Warehouse training program provides an overview and discussion of the role current good manufacturing practices has in the warehouse; and offers an emphasis in receipts, issues, storage, and dis ... Learn more |
 | cGMP: Microbiology in the Workplace: The GMP: Microbiology In the Workplace training program offers a comprehensive overview of microbiology in the workplace, as it relates to current good manufacturing practices. The syllabus of this course inclu ... Learn more |
 | cGMP: Cleaning and Sanitation: This Good Manufacturing Practice (GMP) in Cleaning and Sanitation training program offers a comprehensive overview and a solid introduction to cleaning and sanitation, as it relates to the regulator of quality ... Learn more |
 | cGMP: Documentation and Record Keeping: This training program provides a comprehensive overview of current good manufacturing practices, with an emphasis on the role of proper documentation, and how it is used to provide a history of the manufacturin ... Learn more |
 | cGMP: Contamination Control: This online training course offers a overview of good manufacturing practice with a comprehensive emphasis on contamination control. The program builds on microbiology in the workplace course, GMP03, and addres ... Learn more |
 | cGMP: Production Controls: This program offers an overview of good manufacturing practice, with a comprehensive emphasis on production controls. The program builds on GMP06, the contamination control course. The course will describe and ... Learn more |
 | cGMP: Packaging Controls: The good manufacturing practice in packaging controls program describes cGMP requirements for the control of packaging materials and operations. Students will explore the reasons that labeling problems still co ... Learn more |
 | cGMP: Quality Assurance and Quality Control: This course emphasizes quality assurance and quality control, with respect to good manufacturing practices. Participants explore GMPs as they apply to quality testing, management, manufacturing, and the control ... Learn more |
| cGMP: Pharmaceutical CAPAs: 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 ... Learn more |
 | cGMP: Introduction to Good Manufacturing Practice, An Abridged Course: The cGMP: Introduction to Good Manufacturing Practice, An Abridged Course is a shortened training program used primarily for demonstration purposes only. The full length course includes an introduction to curre ... Learn more |
Online Training: The Benefits of eLearning
- 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.
