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Key Steps for Site Inspection Readiness

About this episode

Louise Uí Fhatharta bio

Quality professional with over 20 years’ experience in Microbiology, Quality Control and Quality Assurance roles in the Pharmaceutical Industry including Sterile Fill Finish and Medical Device.

Involved in site and laboratory expansion projects from design through to method transfer and operational readiness. Supported site in a capacity of Quality, Sterility Assurance and Microbiology Lead oversight during projects. Through Industry experience strong analytical and problem-solving skills have been attained and highly developed strong leadership skills. Successful experience of leading FDA, HPRA and DEKRA Health Authority inspections.