Speak Pharma presents the 3rd edition, taking place in Vienna, Austria, and online on November 10–11, 2026. Industry leaders will examine Contamination Control Strategy (CCS) from a cleaning-validation perspective, focusing on how residue control, equipment cleanability, and lifecycle cleaning validation directly support a robust CCS under Annex 1. The program includes practical approaches for linking cleaning validation limits to contamination-control decisions, integrating analytical and microbiological data into CCS assessments, and improving risk-based control measures in multi-product operations. Through real-world case studies and guided discussions, participants will gain clear, actionable insights to strengthen their cleaning-driven CCS programs. Secure your spot now by submitting a request.
Day 1 – Strategy & Regulatory Alignment
· Case-Based Approach and Evaluation of Recent Warning Letters
· Evolution of Cleaning Validation under Annex 1
· Regulatory and industry expectations in practice
· Building a risk-based CCS framework
· CCS implementation in multi-product facilities
· Digital tools for CCS monitoring and data integrity
· Linking cleaning validation to CCS risk matrices
Day 2 – Implementation & Continuous Improvement
· Best practices in cleaning validation lifecycle
· Sampling and analytical methods
· Integrating environmental and microbiological controls into CCS
· Human factors and operator behaviour in contamination control
· Audit-ready documentation and CAPA integration
· Future direction of cleaning validation under Annex 1
Who Should Join
Professionals overseeing the entire spectrum of cleaning validation programs, from initial development to seamless deployment and ongoing maintenance — especially those integrating these activities into a site-wide Contamination Control Strategy (CCS).
Experts in quality assurance, quality control, microbiology, and regulatory affairs playing pivotal roles in ensuring compliance, contamination control, and alignment with Annex 1 expectations.
Leaders and technical experts responsible for evaluating cleaning systems, reviewing equipment design and cleanability, and providing robust support for on-the-ground implementation of cleaning validation and CCS elements.
Decision-makers at every level seeking a deeper understanding of the science behind cleaning and cleaning validation, including considerations such as residue selection, risk assessment, and how these factors influence the overall CCS.
Professionals involved in environmental monitoring, microbiological oversight, and contamination-risk evaluation who contribute critical data and expertise to the CCS framework.
Engineering and operations personnel responsible for ensuring that facility design, process flow, and equipment configuration support effective contamination control and validated cleaning processes.
Original price was: €1,499.€899Current price is: €899.
2 day Access
Early Bird
Original price was: €2,998.€1,799Current price is: €1,799.
Group Booking 2+1
3 Delegates Attendance
Photos
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