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Introduction to Non-conformance - Aware (PH01002)

Course Description:

Have you heard the term Non-conformance and ever wondered why work seems to stop when a non-conformance occurs? In the Pharmaceutical industry, it is very important that Non-conformances are dealt with in a systematic and organised manner as doing so will ensure the Quality, safety and efficacy of any pharmaceutical product is maintained.  In this course, you'll explore the critical role of non-conformances in quality management: what they are, why their regulation is so important and how to ensure oversight. Delve into effective monitoring techniques that will help your organization maintain peak performance standards! 


Learning Outcome:

In this course, you'll uncover the critical role of identifying and managing Non-conformances in the pharmaceutical industry. By the end of the training, you'll gain a clear understanding of what Non-conformances are, why they arise, and how they should be effectively managed within a GMP environment. You'll also explore the necessity of a systematic approach to handling these issues, learning the essentials of recording, tracking, and resolving Non-conformances. Dive into the detailed processes for documenting, reviewing, and closing out Non-conformances, and discover the pivotal role of a robust recording and tracking system in ensuring compliance and maintaining high quality standards.

Course Features

Modules : 3
Duration : 02:15 Hour(s)
Assessment : Self
Skill Level : Entry

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Course Content(s)


Introduction to Non-conformance - Aware (PHNC0102)

This module introduces the concept of non-conformances, what they are and how they are managed in a pharmaceutical quality 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.

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.

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