Issue Management Foundation
Course Description:
It is not uncommon for issues to arise on a day to day basis in any organisation. In a Good Manufacturing Practice (GMP) environment, it is important that these issues are dealt with in a systemic and effcient manner as the quality of the product can be impacted. This course covers who, when, why and how you should deal with quality events that occur in GMP environment. It covers the importance of raising, recording and dealing with quality issues in a systematic and efficient manner. It also covers the basic understanding of Non-Conformances, Deviations and Corrective Actions and Preventative Actions (CAPAs).
Learning Outcome:
- Define an incident or a problem related to Quality
- Discuss the importance of incident management in GMP environment
- List the steps to be taken after an incident is reported
- Define what a non-conformance is
- Define what a Deviation is
- Explain the process of raising, recording and tracking these
- Explain the importance of finding the root cause of the incident
- Understand the importance of raising corrective and preventative actions
- Define an incident or a problem related to Quality
- Discuss the importance of incident management in GMP environment
- List the steps to be taken after an incident is reported
- Define what a non-conformance is
- Define what a Deviation is
- Explain the process of raising, recording and tracking these
- Explain the importance of finding the root cause of the incident
- Understand the importance of raising corrective and preventative actions
Course Features
| Modules | : | 4 |
| Duration | : | 3 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
Incident Management (CPIM0101)
GMP covers a wide range of quality-related activities, from product development and manufacturing to packaging and distribution. As such, it is important for GMP personnel to be able to identify and deal with day to day quality issues in a timely and efficient manner. This module will cover the who, when, why, and how of quality event reporting in GMP environments. It will also discuss the importance of raising, recording, and dealing with quality issues in a systematic and efficient manner. By the end of this module, GMP personnel should have a better understanding of how to handle daily quality events that occur in their work environment.
Non-conformance - Introduction (CPNC0101)
This module will take you through what non-conformances 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 - Introduction (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.
CAPA - Introduction (CPCP0101)
This module will take you through what CAPAs 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.