Adiuvo areas of expertise include: quality systems development and assessment, radiation and EO sterilization validation, sterilization management, medical device regulations, supplier auditing, nonconformity investigation and resolution, CAPA, FDA 483 response, and training.
Adiuvo QS & SA Consulting offers practical consultative programs designed to enhance your firm’s quality system, regulatory compliance, and sterilization practices.
A unique blend of consultative analysis, technical assistance and laboratory support from several laboratories Adiuvo QS & SA Consulting is “specifically designed to enhance quality systems, provide practical solutions to manufacturing and sterilization issues, and provide consulting services to the customer that will lead to the customer’s self reliance.”
Lisa Foster, Principal, served as Sterigenics Vice President of Quality Assurance for 15 years, the largest contract sterilizer in the world, and seven years as Vice President of Laboratory and Consulting services, providing customers the benefit of her experience, know-how and technology of the world pacesetter in medical sterilization.
Adiuvo has partnered with Center for Risk Based Strategies (CRS). CRS brings complimenting services that will benefit the client focusing on continuous improvement. CRS provides expertise in Science-based Validation strategy, Six Sigma and Lean techniques, statistics, Design of Experiment, Statistical Process Control, and process capability.
Company’s Keywords:
sterilization, sterilization training, auditing, capa, supplier approval, contract sterilizer management & auditing, device design sterilization capability, sterilization technical assistance, sterilization sops, review of technical file related to sterilization, provide rationale for nonconforming loads related to sterilization, dose audit failure, eo qualification, requalification, review of validation reports from third parties or contractors
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