Introduction to Deviations - Aware
Course Description:
In pharmaceutical industry, deviations play an important part in maintaining patient safety and product quality. For this reason, it is important that all employees working in a GMP environment have the basic understanding of what deviations are and how they are raised and managed. This module provides a basic understanding of the roles, responsibilities and processes necessary for recording, raising, resolving and tracking deviations that all employees must have - ensuring everyone is working together towards one common goal!
Learning Outcome:
- What are deviations and the different types;
- Why it is important to raise deviations in the pharmaceutical industry;
- How to raise and manage deviations;
- What a deviations management system is.
- What are deviations and the different types;
- Why it is important to raise deviations in the pharmaceutical industry;
- How to raise and manage deviations;
- What a deviations management system is.
Course Features
| Modules | : | 3 |
| Duration | : | 2 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
Introduction to Deviations (PHDV0102)
In this module, you will learn the basics of Deviations and their management in a GMP environment. You will learn what Deviations are, and why they are raised and monitored. You will also gain an understanding of who is involved in raising, recording and reviewing deviations and the importance of having a systematic process for dealing with them.
Introduction to Deviations Process (PHDV0402)
In this module, you will gain the basic understanding of process followed to manage deviations in a pharmaceutical company. It gives details on how and when to record, investigate and close out deviations. It also gives information on roles and responsibilities of the different stages of the process and the importance of following strict timelines when managing deviations.
Introduction to Deviations Recording System (PHDV0501)
In this module, you will learn the basics on how to record and track Deviations in a systematic manner in a GMP environment. It gives details on how to record, review and close out deviations and the importance of using a recording and tracking system.