Issue Management Foundation
Course Description:
In any pharmaceutical organisation, it's crucial to tackle problems promptly and efficiently to ensure the quality and safety of the pharmaceutical product. This course will help you develop a systematic approach to dealing with day-to-day issues that occur within Good Manufacturing Practice (GMP) environments. Not only will it teach the importance of recording events accurately, but also provide an understanding of Non-Conformances, Deviations and Corrective and Preventative Actions (CAPAs). Mastering these strategies is paramount when navigating GMP requirements while preserving high standards of production excellence.
Learning Outcome:
- Define an incident or a problem related to Quality
- Explain why incident management is important in GMP environment
- Detail what should be done once an incident has occured
- Understand what a non-conformance is
- Explain what a Deviation is
- Understand the process of raising, recording and tracking these
- Explain why it is important to raise corrective and preventative actions
- Define an incident or a problem related to Quality
- Explain why incident management is important in GMP environment
- Detail what should be done once an incident has occured
- Understand what a non-conformance is
- Explain what a Deviation is
- Understand the process of raising, recording and tracking these
- Explain why it is important to raise corrective and preventative actions
Course Features
| Modules | : | 4 |
| Duration | : | 3 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.
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.
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.