CAPA Management Advanced
Course Description:
Why are CAPAs the biggest area of findings in regulatory audits to date? There is still confusion in the industry about when to raise CAPAs, and how to manage and resolve them effectively in a timed manner. This course will provide a detailed understanding of when CAPAs are raised, how to manage them and ensuring they are effective. It covers the importance of communication and closing of CAPAs on time. Details of who is involved in raising, recording and reviewing them and why it is important to have a systematic process of dealing with them to ensure the smooth functioning of the Quality system in a company.
Learning Outcome:
- Understand what a CAPA is
- Explain the CAPA process
- Understand the importance of root cause analysis in managing CAPAs
- Explain what a CAPA management system is and why it is required
- Understand the responsibilities of personnel for a CAPA management system
- Explain the importance of communication in a CAPA management system
- Explain the importance of trending and management responsibilities in a CAPA management system
- Understand what a CAPA is
- Explain the CAPA process
- Understand the importance of root cause analysis in managing CAPAs
- Explain what a CAPA management system is and why it is required
- Understand the responsibilities of personnel for a CAPA management system
- Explain the importance of communication in a CAPA management system
- Explain the importance of trending and management responsibilities in a CAPA management system
Course Features
| Modules | : | 3 |
| Duration | : | 3 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
CAPA Management - Foundation (PHCP0101)
By the end of this module, you will have a basic understanding of what CAPAs are, and why is it important to raise them in order to ensure the quality safety and efficacy of pharmaceutical products. You’ll also have an understanding of who is involved in raising, recording and reviewing CAPAs and why it is important to have a systematic process of managing them.
CAPA Process (PHCP0201)
By the end of this module, you will understand the process by which CAPAs are raised, managed, and reviewed. You will also understand why the actions raised should be SMART and how to carry out effectiveness checks to ensure that the actions implemented have actually worked.
CAPA Management System (PHCP0301)
This module focuses on CAPA management. A system needs to be in place to record and track CAPAs in an organised way in a GMP environment. This is important to ensure that all issues are effectively addressed to ensure the quality safety and efficacy of the products. It gives details on how to record, review and close out CAPAs and the importance of using a recording and tracking system.