A UL course
This program reviews the concept of change control by placing learners in the role of the change control manager. Participants learn to:
- State the key elements of a change control program
- Identify indicators of change
- Follow change control regulations
The program shows how to identify groups involved in change control and describe the impact of change on product, processes, and people.
- Regulatory requirements for change control
- Steps in the basic model of change control
- Indicators of an improper change
- Elements of change control
- Processing and packaging
- US Food and Drug Administration notification
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields