Detecting Foreign Particle Matter (FPM) is a key quality metric in Pharmaceutical product development. If FPM is present in a drug product, it represents a significant challenge for manufacturing, product recalls and of course, a danger to patients.
So what is that particle and how did it get there?
This webinar will review current FDA and USP guidance on the acceptable levels of FPM in different drug formulations, how to determine the source and how to assess the risk that its presence might represent. We will share insights on the current technologies used to identify the particulate material to capture its size and shape, and aid in identification, for both visible and sub visible particles.
If you have ever encountered a particulate issue or simply just want to be better prepared for the future, this webinar is for you.
Key Learning Objectives
- To discover the different analytical options for foreign particulate analysis
- To review the current regulatory guidance on acceptable levels of FPM
- To learn more about the current technologies used in pharmaceutical product development