Dr. Scott Nichols PhD

Former FDA lead inspector of drug substance and drug product manufacturing facilities for biotechnology drugs, and former FDA reviewer of biotechnology drug applications for microbial control, sterility assurance, and microbiological product quality. I have expertise in cGMP compliance, microbial control, sterility assurance, and aseptic processing. I provide advice on remediation strategies for biopharmaceutical manufacturing, including control strategies (bioburden control, cross-contamination control, multi-product manufacturing control), qualification/validation strategies (sterile processes, microbial methods, equipment IQ/OQ/PQ, high-risk emerging technologies including continuous manufacturing), sterile biopharmaceutical manufacturing and testing, and low endotoxin recovery. I have extensive knowledge implementation and interpretations of USP; ICH and FDA guidances; FD&C Act; PHS Act; 21 CFR Parts 210-211, 314, 600-610, and other FDA regulations.