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 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 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 incident or a problem
- Why it is important to manage incidents in the pharmaceutical industry.
- What happens once the incident is raised
- Who is involved in managing the incident
- How are incidents managed
Course Features
Modules | : | 1 |
Duration | : | 30 Minute(s) |
Language | : | English |
Assessment | : | Self |
Skill Level | : | Entry |
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.
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