Deviations Management Advanced
Course Description:
What happens when processes cannot be followed as per written procedures for one reason or another? Deviations can occur anywhere in the manufacturing process and it is a GMP requirement that these are raised, recorded and resolved in a systematic manner. The is course will take you through from understanding what deviations are to the process followed to raise, record, resolve and track how they are managed. It details the roles and responsibilities of the different departments involved in managing Deviations.
Learning Outcome:
- Define deviation and state the different types of deviations
- Identify the importance of raising a deviation
- Explain the deviation process;
- Categorise the deviations into different types;
- Describe the root cause analysis process.
- Explain what a deviation management system is and why it is required;
- Discuss the responsibilities of personnel for a deviation management system;
- Describe the deviation close-out process;
- Explain the importance of communication in a deviation management;
- Explain the importance of trending and management responsibilities in a deviation management.
- Define deviation and state the different types of deviations
- Identify the importance of raising a deviation
- Explain the deviation process;
- Categorise the deviations into different types;
- Describe the root cause analysis process.
- Explain what a deviation management system is and why it is required;
- Discuss the responsibilities of personnel for a deviation management system;
- Describe the deviation close-out process;
- Explain the importance of communication in a deviation management;
- Explain the importance of trending and management responsibilities in a deviation management.
Course Features
| Modules | : | 3 |
| Duration | : | 3 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
Deviations - Foundation (CPDV0101)
This module will take you through what Deviations are, why they are raised and monitored and how this is achieved in a GMP environment. It covers the basics of who is involved in raising, recording and reviewing them and why it is important to have a systematic process of dealing with them.
Deviations - Process (CPDV0201)
This module will focus on the process of dealing with Deviations in a systematic way in a GMP environment. It gives details on how to raise, manage and review them including finding the root cause and finding the corrective actions and preventative actions to avoid recurrence.
Deviations - Management System (CPDV0301)
This module will focus on the recording and tracking of Deviations in a systematic way 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.