CAPA Management Advanced
Course Description:
CAPAs are to date, the biggest area of findings in GMP audit. Why is this the case? This course will provide 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 a smooth functioning of the Quality system in a company.
Learning Outcome:
- Define what CAPA is;
- Explain the CAPA process;
- Discuss the importance and requirement of the CAPA process;
- Identify when the CAPA process should be used;
- List the steps involved in the CAPA process; and
- Explain the differences between corrective actions and preventative actions.
- Explain what a CAPA management system is and why it is required;
- Identify what should be recorded in the CAPA management system;
- Explain the importance of communication in a CAPA management; and
- Describe the CAPA closure process.
- Define what CAPA is;
- Explain the CAPA process;
- Discuss the importance and requirement of the CAPA process;
- Identify when the CAPA process should be used;
- List the steps involved in the CAPA process; and
- Explain the differences between corrective actions and preventative actions.
- Explain what a CAPA management system is and why it is required;
- Identify what should be recorded in the CAPA management system;
- Explain the importance of communication in a CAPA management; and
- Describe the CAPA closure process.
Course Features
| Modules | : | 3 |
| Duration | : | 3 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
CAPA - Introduction (CPCP0101)
This module will take you through what CAPAs are, why they are raised and monitored and how this is achieved in a GMP environment. It covers the basics of who is involved in raising, recording and reviewing them and why it is important to have a systematic process of dealing with them.
CAPA - Process (CPCP0201)
This module will focus on the process of dealing with CAPAs in a systematic way in a GMP environment. It gives details on how to raise, manage and review them. It focus on the importance of having actions that are SMART and ensuring effectiveness checks are carried out.
CAPA - Management System (CPCP0301)
This module will focus on the recording and tracking of CAPAs in a systematic way in a GMP environment. It gives details on how to record, review and close out CAPAs and the importance of using a recording and tracking system.