Issue Management Advanced
Course Description:
Have you heard the terms Non-conformance and Deviations being used in GMP environment? Ever wondered why all activity seems to stop when something goes wrong in a GMP environment? This course will take you through what non-conformances and deviations are, why they are raised and monitored and how this is achieved in a GMP environment. It then moves into raising and managing CAPAs to stop the issues from recurring. Roles and responsibilities are also covered in detail to ensure a smooth functioning of the Quality system in a company.
Learning Outcome:
Define an incident or a problem related to Quality;
Discuss the importance of incident management in GMP environment;
Describe the steps to be taken after an incident is reported;
Define what a non-conformance, Deviation and CAPA is;
Explain the process of raising, recording and tracking these;
Discuss the responsibilities of personnel for a non-conformance, deviation and CAPA management system;
Explain the importance of finding the root cause of the incident;
Understand the importance of raising corrective and preventative actions;
Explain the importance of communication in Issue management;
Explain the importance of trending and management responsibilities in Issue management.
Define an incident or a problem related to Quality;
Discuss the importance of incident management in GMP environment;
Describe the steps to be taken after an incident is reported;
Define what a non-conformance, Deviation and CAPA is;
Explain the process of raising, recording and tracking these;
Discuss the responsibilities of personnel for a non-conformance, deviation and CAPA management system;
Explain the importance of finding the root cause of the incident;
Understand the importance of raising corrective and preventative actions;
Explain the importance of communication in Issue management;
Explain the importance of trending and management responsibilities in Issue management.
Course Features
| Modules | : | 10 |
| Duration | : | 8 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 - Foundation (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.
Non-conformance - Process (CPNC0201)
This module will focus on the process of dealing with Non-conformances 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.
Non-conformance - Management System (CPNC0301)
This module will focus on the recording and tracking of Non-conformances in a systematic way 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.
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.
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.
CAPA - Process (CPCP0201)
This module will focus on the process of dealing with CAPAs in a systematic way in a GMP environment. It gives details on how to raise, manage and review them. It focus on the importance of having actions that are SMART and ensuring effectiveness checks are carried out.
CAPA - Management System (CPCP0301)
This module will focus on the recording and tracking of CAPAs in a systematic way in a GMP environment. It gives details on how to record, review and close out CAPAs and the importance of using a recording and tracking system.