FREE ON-DEMAND WEBINAR

Free On-Demand Webinar

 

Watch this recorded webinar on IV Bag Quality Risk Management & CCI Strategies to comply with regulatory guidelines. 

 

Meet the Presenter

Oliver Stauffer

CEO of PTI

This 1-hour webinar (including Q & A) will cover the following topics:

 

Recent regulatory changes have shifted requirements and strategies for container closure integrity. IV bags and flexible parenteral presentations have experienced the greatest impact from these new perspectives on quality. IV bags have always presented a significant risk. New provisions to Annex 1 have made the requirements for quality risk management (QRM) clear, and USP guidance documents outline the need for greater control. Based on the regulatory requirements and guidance, practical solutions for IV bag container closure integrity should offer non-destructive, practical and deterministic approaches to assure integrity. 

 

This webinar will cover:

• Critical considerations for IV bag QRM
• Guide attendees through strategic approaches to assuring integrity of IV bags and flexible parenteral presentations
• How to satisfy the shifting regulatory environment

PTI offers inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI's inspection technologies are deterministic test methods that produce quantitative test result data. We specialize in offering the entire solution including test method development and equipment validation.