Non-conformance Management Advanced
Course Description:
Have you heard the term Non-conformance being used in GMP environment? Ever wondered why all activity seems to stop when this occurs? This course will take you through detalied information on what non-conformances 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.
Learning Outcome:
- Define non-conformance
- Explain the non-conformance process
- Categorise the types of non-conformance
- Identify the components of root cause analysis
- Explain what a non-conformance management system is and why it is required
- Discuss the responsibilities of personnel for a non-conformance management system
- Describe the non-conformance close-out process
- Explain the importance of communication in a non-conformance management system
- Explain the importance of trending and management responsibilities in a non-conformance management system
- Define non-conformance
- Explain the non-conformance process
- Categorise the types of non-conformance
- Identify the components of root cause analysis
- Explain what a non-conformance management system is and why it is required
- Discuss the responsibilities of personnel for a non-conformance management system
- Describe the non-conformance close-out process
- Explain the importance of communication in a non-conformance management system
- Explain the importance of trending and management responsibilities in a non-conformance management system
Course Features
| Modules | : | 3 |
| Duration | : | 3 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
Non-conformance - Foundation (CPNC0101)
This module will take you through what non-conformances 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.
Non-conformance - Process (CPNC0201)
This module will focus on the process of dealing with Non-conformances in a systematic way in a GMP environment. It gives details on how to raise, manage and review them including finding the root cause and finding the corrective actions and preventative actions to avoid recurrence.
Non-conformance - Management System (CPNC0301)
This module will focus on the recording and tracking of Non-conformances in a systematic way in a GMP environment. It gives details on how to record, review and close out non-conformances and the importance of using a recording and tracking system.