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Services
Quality Systems
Design and implementation of quality systems with expertise in validation strategies, root cause analysis, failure investigations, technology transfer, audit readiness and regulatory compliance.
Quality Anchor
Laboratory Microbiology
Laboratory microbiological management and control strategies: quality control and assurance inclusive systems (instrument routine monitoring, maintenance and validation, media controls, documentation, data management and integrity, LIMS, analyst training and proficiencies); methodology selection; laboratory design; audit readiness.
Manufacturing
Manufacturing microbiological and quality control strategies: cleaning and sanitization inclusive of perspectives from quality, microbiology, engineering and plant floor ; environmental monitoring, microbiological risk and GMP vulnerability assessments; water system monitoring, maintenance and improvement; SOP development.
Rapid Methods
Rapid microbiological innovation: strategy development, validation and execution; rapid microbiological release methods for finished products and raw materials; rapid microbiological methods for microbial identification, cleaning and sanitization and water; innovation for improved efficiencies and effectiveness in laboratory management and throughput.
Preservation
Preservation and method strategies: product specific preservation system design with incorporated testing and regulatory strategies; Method Suitability, Microbial Limits and preservative efficacy testing expertise.
Innovation Anchor
Training & Development
Development and execution of training programs in various areas of manufacturing, GMP, and fundamental microbiology and quality to diverse cultural and organizational teams; mentoring of program trainees.
Training Anchor
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