Case Study – Successfully Taking a New Client out of MHRA Compliance Management Team (CMT) measures

Time: 10:10 am - 10:30 am

Date: 28 April 2020


Each year, the MHRA issues citations to pharmaceutical companies for non-compliance with GMP/GCP/GDP/GLP regulations, including Data Integrity which encompasses all of the GxP’s. This case study explores the challenges faced in responding to a citation on Data Integrity. How responding to the MHRA in a prompt timely manner with a well structured plan, enabled the removal from CMT measures. Further exploring the challenges in delivering the plan and finalising with client determination of the value £’s of removal from CMT measures


  • David Thompson Principal Consultant - Clarity Compliance Solutions Ltd

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