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Laboratory Control System Operations in a GMP Environment
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Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations
In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutic...