Since the Medicines and Healthcare products Regulatory Authority (MHRA) released the consultation document ‘MHRA GxP Data Integrity Definitions and Guidance for Industry’ in July 2016, the industry has been trying to get to grips with what it means and how to apply the guidance.  The guidance is yet to be formalised and published, but it is probably just a matter of time.  To that effect, many companies are considering the implications of the guidance.

 

If you want to find out more about GxP Data Integrity, come along to the HSRAA Annual Conference 2018 in Brighton, UK.  You will have the chance to hear the following speakers:

 

  • David Thompson, a Computer Systems Validation and Compliance expert at Clarity Compliance who will talk about ‘Developing the Data Integrity Governance System and “Weaving it into the Fabric of the organisation”’. He will discuss the challenges and how these challenges can be overcome, using real life examples of clients and organisations implementations.

 

  • David Robinson, a QA Consultant and Qualified Person (QP), who will take us through a case study in which batch records were deliberately falsified. He will look at how this was discovered, what happened and what actions were taken, as well as the outcome.

 

Of course, the agenda contains much more than this. Check out the full agenda online and come back again soon for news of other conference presentations.