A Straightforward Path Toward Regulatory Compliance, Data Integrity, And Computer Systems Validation
Implementing new microbial testing and identification solutions in a cGMP environment requires a clear, validated path to regulatory compliance. Navigating the stringent requirements from regulatory agencies, from assay qualification to ensuring robust data integrity, can introduce costly complications if not planned correctly.
This educational session draws on real-world experience to share effective strategies for implementing and validating microbial identification systems. You'll gain clarity on the essential components of a complete computer systems validation plan, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and 21 CFR Part 11 compliance. Understand the specific regulatory guidance surrounding validation and explore a comprehensive solution designed to meet these demanding requirements head-on. Watch the full webinar to learn how to achieve seamless validation for your microbial testing program.
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