Wednesday, May 31, 11:00 am EDT
This 1-hour webinar (including Q & A) will cover the following topic:
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, and guide attendees through strategic approaches to assuring integrity of IV bags and flexible parenteral presentations to satisfy the shifting regulatory environment.
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