Issue Management
Course Description:
Unexpected events are almost guaranteed to happen on a daily basis in any organisation.
Pharmaceutical industries are required to follow Good Manufacturing Practices (GMP) which cover a wide range of quality-related activities, from product development and manufacturing to packaging and distribution. As such, it is important for anyone working in a GMP environment to be able to identify and deal with day-to-day quality issues in a timely and efficient manner. This course 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 systematically and efficiently. 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.
Learning Outcome:
- What is an issue or a problem
- Discuss the importance of issue management
- Recognise how to address an issue
- Differentiate between raising and reporting
- Identify the roles and responsibilities
- Identify the steps to follow
- What is an issue or a problem
- Discuss the importance of issue management
- Recognise how to address an issue
- Differentiate between raising and reporting
- Identify the roles and responsibilities
- Identify the steps to follow
Course Features
| Modules | : | 2 |
| Duration | : | 1 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
Course Content(s)
Introduction to Issue Management (PHIM0103)
This module covers the importance of raising, recording and dealing with quality issues and events that occur in the Pharmaceutical GMP environment.
Issue Management - The Process (PHIM0202)
This module dives into why following a systematic and efficient process is important and gives the detailed process to follow when managing issues in a GMP environment.