FAT, SAT, IQ, OQ, SMEPAC - What Does It All Really Mean?

Qualification, validation, and supporting documentation are familiar parts of pharmaceutical regulation. Ensuring you are upholding regulatory compliance when implementing a process puts you one step ahead when eventual third-party auditing takes place.

The world of regulatory compliance can be very confusing when taking a broad overview of a full process with many different steps and factors. There is a lot of industry jargon, varying testing protocols, and task-specific applications that all require consideration. This is where choosing the right trusted process equipment manufacturer can provide endless value as they help guide you along the right path when it comes to qualifying your process.

This webinar dives into the correct timeline for process validation as well as how to apply the appropriate qualification methods and create supporting documentation. This, in turn, creates the solid foundation needed for a regulatory audit. Furthermore, we examine the tasks required at each stage of the validation lifecycle and highlight the importance of linking the URS to every validation step to ensure complete compliance.