Dear All
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.
Kind
Regards
Sarah Curno
HSRAA Marketing
Coordinator
Kind Regards
Sarah Curno
Consultant
Hedian Records Management
Operational Committee Member and Marketing and Training Coordinator for the Health Sciences Records and Archives Association (HSRAA)
Skype: Sarah Curno
Telephone: +44 (0) 1628 672509
Mobile: +44 (0) 7785 326 150
For Records Management and Archivists training check out the Health Sciences Records and Archives (HSRAA) website at https://the-hsraa.org/training
The HSRAA is a non-profit organisation supporting Records Managers, Archivists and other Information Management professionals in the science/health sector.