Course Title: Regulatory Inspection Ready
Duration: 1 Day
Course Description:
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.
Course structure
This is a practical course delivered by experienced NHS R&D managers who work in the NHS and have direct experience of managing regulatory inspection in their organisations. Sessions include slide presentations but are also interactive and an opportunity to learn and share with peers. An essential workbook will be provided to all delegates.
Who is the Course for?
The course is designed for all staff involved in research management or for those who want to learn more about the Inspection process. This might include R&D managers, Sponsor representatives, quality managers, facilitators, research governance staff, research nurses, pharmacy teams, study coordinators and investigator site staff.
Learning Objectives:
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
All of the courses in our prospectus are available to run in your local organisation or region. A discounted price can be offered if a room can be provided free of charge or for guaranteed number of delegates. All courses require at least 15 delegates to run. We have various pricing structures for hosting an in house course.
If you would like to host a course then please contact the team for further discussion on info@rdforum.org.uk
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