Course Description:
To date, management of Non-conformances, Deviations and CAPAs is still one of the top findings in regulatory audits. Ever wondered why all activity seems to stop when something goes wrong in a GMP environment? This course provides an in-depth and comprehensive understanding of what non-conformances, deviations and CAPAs are, why they are raised and monitored and how this is achieved in an organised and systematic manner so that all issues are resolved on time in an efficient manner. Roles and responsibilities are also covered in detail to ensure the smooth functioning of the Quality system in a pharmaceutical company.
Learning Outcome:
- Define an incident or a problem related to Quality
- Explain the importance of managing Quality issues
- Understand what happens once a quality issue is raised
- Understand the differences in a non-conformance, Deviation and CAPA
- Explain the importance of the process of raising, recording and tracking these
- Understand the importance of using the root cause analysis and risk assessment in managing the incident
- 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 |
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Course Content(s)
Incident Management (PHIM0101)
This module covers the importance of raising, recording and dealing with quality issues and events that occur in the Pharmaceutical GMP environment. Learn why following a systematic and efficient process is important and who, when, why and how you should deal with quality issues.
Non-conformance Management - Foundation (PHNC0101)
In this module, you will learn the importance of raising and managing Non-conformances. By the end of the training, you will understand what non-conformances are, why they are raised and monitored and how they are managed in a pharmaceutical GMP environment. You will also understand why it is important to have a systematic process of dealing with them.
Non-conformance Process (PHNC0201)
In this module, you will learn how to manage 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 (PHNC0301)
By the end of this module, you will understand how non-conformances are tracked and recorded 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 Management - Foundation (PHDV0101)
In this module, you will learn how to manage Deviations 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.
Deviations Process (PHDV0201)
By the end of this module, you will understand the requirement of tracking and recording Deviations in a systematic way in a pharmaceutical company. It gives details on how to record, review and close out Deviations and the importance of using a recording and tracking system when following GMP.
Deviations Management System (PHDV0301)
By the end of this module, you will learn 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.
CAPA Management - Foundation (PHCP0101)
By the end of this module, you will have a basic understanding of what CAPAs are, and why is it important to raise them in order to ensure the quality safety and efficacy of pharmaceutical products. You’ll also have an understanding of who is involved in raising, recording and reviewing CAPAs and why it is important to have a systematic process of managing them.
CAPA Process (PHCP0201)
By the end of this module, you will understand the process by which CAPAs are raised, managed, and reviewed. You will also understand why the actions raised should be SMART and how to carry out effectiveness checks to ensure that the actions implemented have actually worked.
CAPA Management System (PHCP0301)
This module focuses on CAPA management. A system needs to be in place to record and track CAPAs in an organised way in a GMP environment. This is important to ensure that all issues are effectively addressed to ensure the quality safety and efficacy of the products. It gives details on how to record, review and close out CAPAs and the importance of using a recording and tracking system.
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