Issue Management (PH00802)

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.