Best Practices in Environmental Monitoring 23rd May – Portmarnock, Dublin
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ENVIRONMENTAL MONITORING DRAFT OUTLINE AGENDA – THURSDAY 23rd May 2024
AGENDA
| 09.30 – 09.40 | Chairs Welcome Dr. Tim Sandle – Head of GxP Compliance, Sterility Assurance & Quality Risk Management, BPL and Pharmig Committee |
| 09.40 – 10.20 | Back to basics: What the environmental monitoring programme needs to contain Marsha Steed – Founder & President, Steed MicroBio LLC |
| 10.20 – 11.00 | EM and what Annex 1 requires Patrick Nieuwenhuizen – Director, Principal Consultant, Pharmalex |
| 11.00 – 11.30 | Mingle with the exhibitors over tea & coffee |
| 11.30 – 12.10 | Knowing your microflora and understanding the sources of contamination in your environment Edel Fitzmaurice – Quality Director, QP, Fitzmaurice Scientific Ltd |
| 12.10 – 13.10 | Lunch |
| 13.10 – 13.50 | What to do with environmental monitoring data? (standard slot time, ~40 minutes)
Monica Di Matta – Quality Risk Manager, BPL & |
| 13.50 – 14.00 | Case studies in EM – how to run effective investigations Dr. Tim Sandle – Head of GxP Compliance, Sterility Assurance & Quality Risk Management, BPL |
| 14.00 – 14.20 | Afternoon tea & coffee with the exhibitors |
| 14.20 – 15.20 | Risk based approach to setting environmental monitoring locations (50/60mins)
Monica Di Matta – Quality Risk Manager, BPL & |
| 15.20 – 16.20 | Contamination control strategy panel discussion – how to use environmental monitoring to manage contamination risks (60 mins) Tim Sandle, Edel Fitzmaurice, Patrick Nieuwenhuizen, Monica Di Matta, Joanna Wolodkowi, Marsha Steed |
| 16.20 – 16.30 | Closing remarks and end of meeting |
