Interactive Workshop: FDA Approved Method of Viable Particulate Monitoring for Annex 1, 11 & 15 Compliance

Register now to join us for an interactive workshop on the 7th May 2025, to discuss the role of Biofluorescent Particle Counting to meet the challenges of Annex 1 and continuous EM, in drug product manufacturing of biologics

When: 7th May 2025, 9:00 – 13:00

Where: NIBRT Facility, Dublin

This event is a collaboration with global industry experts, using NIRBT’s new Fill Finish line to give a practical perspective on the adoption of the biofluorescent particle counting technology for continuous manufacturing, at Grade A.

As Biopharma professionals in Engineering and Operations, Microbiology, Quality and Regulatory Affairs, you will get the opportunity to experience the application of BFPC (Biofluorescent Particle Counting) in continuous EM at Grade A and how this can be used to meet your needs of the future, today!

This is a live demonstration, in real-time and not to be missed!

REGISTER

Agenda

09:00 – 09:30 – Reception and Registration

09:30 – 09:40 – Welcome and Opening Remarks

Speaker: NIBRT

09:40 – 10:00 – Life Science Challenges: Regulatory Landscape & Requirements

  • ICH Q9 (QRM), Q10 (PQS), and Q11 (PMS)
  • Pharma 5.0 (PAT & RTRT)
  • Annex 1 (GMP), Annex 11 (DI), and Annex 15 (Q&V) for Continuous EM

    Speaker: Conor Murray, Chair Healthcare Standards, NSAI, Irish SME at ISO/TC 209

10:00 – 10:20 – Existing EM Landscape: Challenges with Traditional and Continuous EM

  • Manual intervention and agar exposure times in airborne viable sampling and settle plates

    Speaker: Kevin Lomasney

10:20 – 10:50 – Application of ARMM in Grade A EM for Annex 1, 11 & 15 Compliance

  • BioFluorescent Particle Counting (BFPC) for real-time detection in predictive quality and digital twin in continuous manufacturing

    Speaker: Mike Dingle, Microbiologist, BFPC Product Specialist, TSI

10:50 – 11:00 – Coffee Break

11:00 – 12:30 – TOUR “A” & TOUR “B” – Live Demonstration

  • TOUR A: NIBRT Facility Tour (45 minutes)
  • TOUR B: Fill Finish Line Tour with Biotrak BFPC (45 minutes)

12:30 – 13:00 – Lunch & Networking

Discussion, Q&A, Feedback, and Closing Remarks