Key Steps for Site Inspection Readiness
- Listen time: 17m
Synopsis:
This podcast discusses the essentials of preparing for inspections in regulated industries. We cover key strategies for ensuring compliance, maintaining thorough documentation, and fostering a culture of continuous readiness. Our expert guest will share their insights and experiences, providing practical tips to help organisations stay prepared for any inspection. Tune in to learn how to navigate the complexities of inspection readiness and ensure your operations are always up to standard.
This podcast discusses the essentials of preparing for inspections in regulated industries. We cover key strategies for ensuring compliance, maintaining thorough documentation, and fostering a culture of continuous readiness. Our expert guest will share their insights and experiences, providing practical tips to help organisations stay prepared for any inspection. Tune in to learn how to navigate the complexities of inspection readiness and ensure your operations are always up to standard.
Bio:
Louise Uí Fhatharta
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