Laura Brown Training and Development
providing quality in-house training and QA solutions
 
Email : info@laurabrowndevelopment.com Tel : +44(0)1494 873 566
Laura Brown Training
 
International expertise for in-house customised technical and management skill training, and quality assurance audit for Pharmaceutical, Biotechnology, Medical Device and Healthcare organisations.
 
Home
About Us
Clients
In-House Courses
GCP courses
GXP courses
Project Management
Technical Pharma
Management and Personal skills
Pharma "mini MBA"
Pharma Leadership skills
Support staff/administrators
Training Consultancy/other services
Audit services
Publications
Useful Links
Contact/Enquiries

 

 

GXP News

Data Integrity

MHRA require “Sufficient training in data integrity principles provided to all appropriate staff (including senior management)” March 2018

Besides the FDA, WHO and PICs the MHRA published “GXP data integrity guidance and definitions” in March 2018 GXP data integrity guidance.

The new MHRA guide provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the GXP pharmaceutical lifecycle GCP, GMP, GLP and GvP. It has a high degree of alignment with documents published by other regulators such as PIC/S, WHO, OECD (guidance and advisory documents on GLP) and EMA. It is designed to facilitate compliance through education and clarifying the MHRA’s position on data integrity and the minimum expectation to achieve compliance.

Like the FDA and WHO guidance the MHRA guidance requires training in data integrity for compliance. An example of a public course is available at https://management-forum.co.uk. Training on Data Integrity to ensure compliance is available – contact Laura Brown info@laurabrowndevelopment.com for more information for in-house training.

To find out more about any of these courses or to discuss how a course could be tailored to your specific needs, please contact Laura Brown at info@laurabrowndevelopment.com