Integrity Assurance Strategy for Single Use Assemblies

WEBINAR

Single-use technology is a fairly new industry compared to others, with respects to specific regulations and compendial standards. This webinar will provide different strategies available to facilitate integrity assurance of the single-use assembly. In the absence of a defined regulatory framework, we will discuss a three pillar integrity assurance strategy that includes quality by design, quality risk management, and  operator training.

In this webinar, you will learn:

• Quality by design approach of thoroughly assessing components before they are ever used to ensure the integrity of the single use assembly. 
• Quality risk management with respects to qualification of junctions, in-process testing, and a variety of application relevant release tests.
• Best practices for handling single use assemblies and operator training.