A UL EduNeering course
This course covers the definition and purpose of post-approval changes (PAC). It explores the four categories of change—components and composition, scale of manufacture, site of manufacture, and manufacturing—and the requirements for each level of change. Participants will learn about PAC guidance and how these documents are used to notify the US Food and Drug Administration (FDA) of changes to an approved pharmaceutical application. The course also covers the levels of post-approval changes and the recommended chemistry, manufacturing, and control requirements for each level.
- Defining post-approval changes
- Four categories of change
- PAC guidance documents
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields