Regulatory Inspection Ready
This course is aimed at those who deliver research in a healthcare setting either in a Sponsor team or as a Host, and that maybe subject to regulatory inspection. Preparation for Inspection is critical but compliance driven from preparation rather than from quality systems can lead to poor practice and Inspection findings.
Last minute changes just prior to a visit can be very unhelpful and in some cases misleading and so this course will help delegates understand how to become inspection-ready for any inspection. Delegates will learn strategies that build confidence for an inspection from any of the regulators for example the MHRA, Human Tissue Authority or Human Embryology & Fertilisation Authority.
Upon successful completion of the course, participants should be able to:
- Explain the types of inspections, their purpose and jurisdiction that an active research organisation may experience
- Develop an action plan to prepare for Inspection
- Develop a strategy to assure compliance to legislation
- Have some knowledge of previous inspection findings
Gain an understanding of corrective actions and preventative actions
