Deviations Management - Complete
Course Description:
In pharmaceutical manufacturing, it is quite often that something happens so that an established process cannot be followed. This is called a Deviation and to ensure the quality and safety of a pharmaceutical product it is important that they are dealt with immediately. In accordance with GMP regulations, specific procedures are necessary for raising and recording these issues to ensure an effective resolution is achieved. This course provides an in-depth understanding of the roles, responsibilities and processes necessary for recording, raising, resolving and tracking deviations and the importance of communication across all departments involved - ensuring everyone is working together towards one common goal!
Learning Outcome:
- Understand what a deviation is and the importance of raising a deviation
- Explain the deviation process;
- Discuss what a deviation management system is and why it is required;
- Understand the importance of Root Cause Analysis and Risk assessment in managing deviations;
- Explain the importance of communication in deviation management;
- Explain the importance of trending and management responsibilities in deviation management.
- Understand what a deviation is and the importance of raising a deviation
- Explain the deviation process;
- Discuss what a deviation management system is and why it is required;
- Understand the importance of Root Cause Analysis and Risk assessment in managing deviations;
- Explain the importance of communication in deviation management;
- Explain the importance of trending and management responsibilities in deviation management.
Course Features
| Modules | : | 5 |
| Duration | : | 4 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
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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.
Deviations Process - Practitioner (PHDV0203)
This module gives the deeper understanding of process followed to manage deviations in a pharmaceutical company. It gives details on how and when to record, the timelines to be followed. It gives details of who is responsible for what and how to carry out the investigations required. This is module is ideal for people who are carrying out the process of managing deviations.
Deviations Recording System - Practitioner (PHDV0302)
This module gives the deeper understanding on how to record and track Deviations in a systematic manner in a GMP environment. It gives details on the importance of having a recording system, what information should be captured and who is responsible for the recording system. It also gives details on the importance of communication in management of deviations and the role of senior management in deviation management.