Non-conformance Management - Complete (PH00402)
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Course Description:
Understand in detail how to raise, record, resolve, and track non-conformances to ensure quality.
Learning Outcome:
Course Features
| Modules | : | 8 |
| Duration | : | 5.5 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
Introduction to Non-conformance - Aware (PHNC0102)
Non-conformance Recording System - Practitioner (PHNC0302)
Non-conformance Process - Practitioner (PHNC0202)
Introduction to Non-conformance Recording System - Aware (PHNC0501)
In this module, you will learn the basics on how to record and track non-conformances in a systematic manner 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.
Introduction to Non-conformance Process - Aware (PHNC0401)
In this module, you will gain the basic understanding of process followed to manage non-conformances in a pharmaceutical manufacturing. It gives details on how and when to record, investigate and close out non-conformances. It also gives information on roles and responsibilities of the different stages of the process and the importance of following strict timelines when managing non-conformances.
Raising Non-conformances (PHNC0601)
In this module you will learn the process to be followed when a non-conformance occurs and the importance of raising it on time. It also covers the importance of documentation and what should be recorded. Once a record has been created, learn how to evaluate the issue that has occurred.
Investigating Non-conformances (PHNC0701)
This module focuses on investigating non-conformances and the criteria required to initiate an investigation. You’ll learn how to determine the scope of the investigation, and how to use different approaches to conduct a successful investigation. This module also provides insight into implementing corrective and preventive actions (CAPAs) to resolve the issue and prevent its recurrence.
Closing Non-conformances (PHNC0801)
This module focuses on the importance of using a a step-by-step process to close non-conformances. It covers why it is important to close non-conformances and explains when and how to initiate the closing process. You will also learn the importance of periodic review of the non-conformance system, how to do a detailed review and understand who is in the process.