Non-conformance Process - Practitioner (PH01701)
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Course Description:
Master when & how to raise and document non-conformances, conduct investigations & assign roles to meet GMP timelines & compliance needs.
Learning Outcome:
Course Features
| Modules | : | 4 |
| Duration | : | 1010 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
Non-conformance Process - Practitioner (PHNC0202)
In this module you will gain a detailed understanding of the process to follow when managing non-conformances. You will learn, when and how to document non-conformances, the critical timelines to adhere to, and the roles and responsibilities involved. Additionally, you will learn the essential steps for conducting thorough investigation to find the root cause.
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.