Haşim Solmaz
- Airborne and Non-Viable Contamination
Discover Contamination Control 360°: Aligning Science and Standards in Dublin, where global expertise connects with European excellence.
AGENDA
08:30 - 09:00
Registration, Tea and Coffee
09:00 - 09:45
Cleanroom Contamination
Airborne and Non-Viable Contamination
Haşim Solmaz, LWS
Airborne and Non-Viable Contamination
Haşim Solmaz, LWS
09:45 - 10:30
NIBRT Facility Tour
10:30 - 11:00
Coffee Break
11:00 - 11:45
Sterile Processes
New Industry Guidance on Materials Transfer into Cleanrooms, BSCs, RABS, and Isolators
Jim Polarine, STERIS
New Industry Guidance on Materials Transfer into Cleanrooms, BSCs, RABS, and Isolators
Jim Polarine, STERIS
11:45 - 12:30
Sterile Processes
Annex 1 and the Sterilization of Indirect Part That Contact Consumables
Maria Ginnelly, Bristol Meyers Squibb
Annex 1 and the Sterilization of Indirect Part That Contact Consumables
Maria Ginnelly, Bristol Meyers Squibb
12:30 - 13:30
Lunch
13:30 - 14:15
Environmental Monitoring
Case Study: Annex 1 CCS and Digital EM Systems
Jason Kelly, LWS
Case Study: Annex 1 CCS and Digital EM Systems
Jason Kelly, LWS
14:15 - 15:00
Environmental Monitoring
Responding to Contamination Events: Investigation, Root Cause, and Recovery
Aaron Lamm, Orion GXP Consulting
Responding to Contamination Events: Investigation, Root Cause, and Recovery
Aaron Lamm, Orion GXP Consulting
15:00 - 15:30
Coffee Break
15:30 - 16:15
Regulatory Compliance
Advancing Contamination Control Strategies and Their Influence on Primary Packaging
Niamh Bissett, West Pharma Services
Advancing Contamination Control Strategies and Their Influence on Primary Packaging
Niamh Bissett, West Pharma Services
16:15 - 17:00
Regulatory Compliance
Evaluating Annex 1 Compliance: Real-World Control Strategies and QP Release Challanges
Eleanor Loughman, MIAS Pharma
Evaluating Annex 1 Compliance: Real-World Control Strategies and QP Release Challanges
Eleanor Loughman, MIAS Pharma
17:00 - 17.30
Day end wrap-up panel Q&A Session Moderator: TBC
