Deviations Process - Practitioner
Course Description:
In the Pharmaceutical industry, it is very important that Deviations are dealt with in a systematic and organised manner as doing so will ensure the Quality, safety and efficacy of any pharmaceutical product is maintained. As such, it is essential for employees responsible for managing deviations in every department to have an in-depth understanding of the process, and the importance of having timelines to manage deviations. This training module also covers the importance of risk assessment and a detailed root cause analysis to find the right corrective and preventive actions if any. By the end of this course, employees will have a deeper understanding of how to identify and manage deviations in order to be compliant with GMP requirements.
Learning Outcome:
- Explain the deviation process;
- Categorise the deviations into different types;
- Describe the root cause analysis process;
- Describe the risk assessment process;
- Define Corrective Action and Preventive Action (CAPA) and explain how they are raised;
- Describe the deviation close out process.
- Explain the deviation process;
- Categorise the deviations into different types;
- Describe the root cause analysis process;
- Describe the risk assessment process;
- Define Corrective Action and Preventive Action (CAPA) and explain how they are raised;
- Describe the deviation close out process.
Course Features
| Modules | : | 1 |
| Duration | : | 45 Minute(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
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Course Content(s)
Deviations Process - Practitioner (PHDV0203)
This module gives the deeper understanding of process followed to manage deviations in a pharmaceutical company. It gives details on how and when to record, the timelines to be followed. It gives details of who is responsible for what and how to carry out the investigations required. This is module is ideal for people who are carrying out the process of managing deviations.