2022 PDA Quality & Regulations Conference

We’ll be at the conference focusing on “How industry and regulators will use data to drive continuous improvement of products and better patient outcomes” in the context of quality and regulatory compliance. Topics will include how to use data contained within quality systems, manufacturing sites, labs, etc. to drive continued product and process knowledge.

Regulators from the Food and Drug Administration (FDA), European Medicines Agency (EMA), etc. will discuss how they use data provided by clinical trial sponsors, marketing authorization holders, manufacturers, parallel importers/distributors, post-market complaint and pharmacovigilance data to develop quality oversight. Leading industry speakers will share case studies featuring “how-to” use this data to drive product and process improvements.

Stop By TSI Booth

Stop by our booth to chat about our Annex 1 ready BioTrak^® Real-Time Viable Particle Counter (a biofluorescent particle detector) that eliminates aseptic interventions for microbial monitoring. It combines viable particle counting—also called biofluorescent particle counting (BFPC)—with sample capture capability and ISO-compliant total particle counting to offer a complete solution for pharmaceutical environmental monitoring. In addition to the BioTrak Real-time Viable Particle Counter, we'll have on-hand our full suite of particle counting instruments that when coupled with TSI FMS Software, no other system does more to prevent loss of data.

Learn More

Watch video to see how the BioTrak Real-Time Viable Particle Counter is meeting Annex 1 requirements >