Non-conformance Management Advanced
Course Description:
In the pharmaceutical industry dealing with non-conformances is still one of the top findings in regulatory audits. Wonder what causes them and why they're so crucial for regulation compliance? This course gives you an in-depth and comprehensive understanding of non-conformances, offering insights on who is responsible for raising, recording and reviewing these vital elements. Follow along as we explore not just their importance but how you can ensure your business stays compliant through systematic processes that help manage the issues effectively.
Learning Outcome:
- Understand what a non-conformance is
- Explain the non-conformance process
- Understand the importance of root cause analysis in managing Non-conformances
- Explain what a non-conformance management system is and why it is required
- Understand the responsibilities of personnel for a non-conformance management system
- 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
- Understand what a non-conformance is
- Explain the non-conformance process
- Understand the importance of root cause analysis in managing Non-conformances
- Explain what a non-conformance management system is and why it is required
- Understand the responsibilities of personnel for a non-conformance management system
- 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 Management - Foundation (PHNC0101)
In this module, you will learn the importance of raising and managing Non-conformances. By the end of the training, you will understand what non-conformances are, why they are raised and monitored and how they are managed in a pharmaceutical GMP environment. You will also understand why it is important to have a systematic process of dealing with them.
Non-conformance Process (PHNC0201)
In this module, you will learn how to manage 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 (PHNC0301)
By the end of this module, you will understand how non-conformances are tracked and recorded 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.