Non-conformance Management - Complete (PH00402)
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:
This course provides an in-depth and comprehensive understanding of what non-conformances are, why they are raised and monitored and how this can be achieved in a GMP environment. You'll explore roles, responsibilities and processes necessary for recording, raising, resolving and tracking non-conformances and understand the importance of communication across all departments involved - ensuring everyone is working together towards one common goal!
This course provides an in-depth and comprehensive understanding of what non-conformances are, why they are raised and monitored and how this can be achieved in a GMP environment. You'll explore roles, responsibilities and processes necessary for recording, raising, resolving and tracking non-conformances and understand the importance of communication across all departments involved - ensuring everyone is working together towards one common goal!
Course Features
| Modules | : | 8 |
| Duration | : | 05:30 Hour(s) |
| Assessment | : | Self |
| Skill Level | : | Entry |
*Try for Free: Enrol to start your 7-day full access free trial.
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.
.png)
.png)
.png)