PDA From Findings to Fixes: Strengthening CCS in Aseptic Manufacturing Workshop 2025
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- Case-based risk mapping: Identify contamination risks in a sterile manufacturing process and design control measures.
- Mock regulatory inspection: Practice responding to real Annex 1–style questions about your CCS.
- Data trend analysis: Review mock environmental and utility data to detect trends and assess control effectiveness.
- Root cause investigation: Work through realistic contamination scenarios and propose CAPA improvements.
Highlighted Presenters
Key Presenters
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David Keen, MRSB CBiol
Ecolab Life Sciences
Director Pharmaceutical Microbiology & Consulting
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Workshop Chair
The Minds Behind the Insights
Agenda
Discover What's Happening Each Day
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South Korea Standard Time Standard Time (UTC +9:00)
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CCS as A Path to Productivity: Cleanroom Requalification
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Coffee Break
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Root Cause Analysis of CCS Failures: Tools and Techniques
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Lunch Break
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Tracking and Trending Tool Demonstration: Charles River's Microbial Identification Services and Trend Analysis Solution
Jeonghun Shin’s presentation aligns with Charles River’s Contamination Control Strategy by introducing microbial identification services that support proactive contamination management. He highlights how the T&T Tool enables traceable environmental monitoring through data tracking and trend analysis. Using 21 CFR Part 11-compliant tools, the system ensures secure handling of microbial data, including frequency and distribution of identified organisms—providing actionable insights for risk assessment and contamination control.
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Corrective and Preventive Actions (CAPA) Linked to CCS Gaps
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Break
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Mock Audit Exercises: Evaluating CCS Readiness
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Location and Travel
Venue Details and Accommodations
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Registration
Pricing Options
Standard Registration
Member Price
USD 499Non-Member
USD 499
Presenters
PDA events bring together top-notch industry experts, innovators, and practitioners who are shaping the future of pharmaceutical science and manufacturing. Our presenters are selected for their experience, insight, and commitment to elevating the global community through knowledge sharing.
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Exhibitors
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