Le Lézard
Classified in: Mining industry
Subject: Conference

One Day Course: Data Integrity and Document Management for GxP Compliance (London, United Kingdom - September 27, 2019) - ResearchAndMarkets.com

The "Data Integrity and Document Management for GxP Compliance" conference has been added to ResearchAndMarkets.com's offering.

Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This course will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

Course Overview

Data integrity is now a focus for regulatory inspections, with both EU and FDA inspectors increasingly observing violations during GxP inspections. It has become a critical issue in document governance and regulators expect staff working in GxP roles to have been trained in this important area.

This concise course covers the background to data integrity, why it is important and how its requirements affect both paper-based and computer-based systems. The course will include discussion of the recently finalised MHRA data integrity guide which 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). You will gain an understanding of the requirements for ensuring data integrity, review data integrity inspection findings, and get practical advice on defining and implementing an appropriate data governance process for compliance with data integrity requirements.

Benefits of attending:

Who Should Attend:

This course is designed for managers and staff from all GxP areas in the pharmaceutical and medical device industries who are responsible for the creation, review, approval and/or reporting of data to ensure data integrity, in particular those working in:

QA personnel from CROs/CMOs and GxP auditors responsible for carrying out audits and self-inspections or external audits will also benefit from the programme.


Principles of data integrity and good documentation practice

Data integrity regulations and guidelines

Document management and data integrity inspection findings

QMS considerations for Data integrity and documentation

Data integrity for computer systems

Discussion of document and data integrity issues

Final questions and summary discussion

For more information about this conference visit https://www.researchandmarkets.com/r/blywal

These press releases may also interest you

at 00:00
OXIS Energy UK Ltd and Sanyo Trading Company Ltd have embarked on an ambitious plan to bring the latest in Lithium Sulfur (Li-S) cell and battery systems technology into Japan. They have signed a Trading Partnership Agreement, whereby both companies...

19 nov 2019
Leading international industrial services provider Bilfinger took ADIPEC's visitors on a journey of its extensive service portfolio that it offers clients throughout the entire lifecycle of a plant. As Bilfinger's main objectives are to enhance the...

19 nov 2019
In November 2019, the Government of the Brazilian state of Amapá named INNOsource the new owner of almost 10 million tons of export-ready manganese ore. The new owners of the pile have promised to join efforts toward recovery from recent mining...

19 nov 2019
This news release is issued by Mr. Gary Cope ("Mr. Cope") pursuant to the early warning requirements of Canada's National Instruments 62-104 and 62-103 with respect to common shares ("Common Shares") and warrants ("Warrants") of Orex Minerals Inc....

19 nov 2019
Atico Mining Corporation (the "Company" or "Atico") today announced its financial results for the three months ended September 30, 2019 ("Q3-2019"), posting income from mining operations of $2.5 million and a net loss of $0.3 million. Fernando E....

19 nov 2019
TimkenSteel Corporation , today announced plans to close its TimkenSteel Material Services facility in Houston, Texas, in the first quarter of 2020. The 100,000-square-foot operation currently employs approximately 100...

News published on 5 june 2019 at 10:50 and distributed by: