Learn how to assure data integrity in the laboratory from the perspective of laboratory management, supervisors and technicians.
There is currently a great deal of regulatory focus on data integrity, especially in the QC Laboratory. This is causing pharmaceutical (and other) companies to re-examine their practices and processes and their use of analytical instruments and data management systems in order to not only assure data integrity, but to do so in a way that is capable of demonstrating compliance with international regulatory requirements.
In this webinar you will learn about the risks associated with a lack of data integrity and gain a background and overview of current and future regulatory trends.
What is covered?
- What are the risks associated with a lack of data integrity and a background and overview of current and future regulatory trends
- Current regulatory guidance
- How risks to data integrity arise and what to do to address the cultural and technical risks
- How modern laboratory instruments and data management systems can assure technical compliance with data integrity requirements.
By viewing this webinar you will learn ...
- why data integrity is important in assuring product quality and patient safety
- why there is a significant focus on data integrity amongst international regulators
- key steps to take to assure data integrity in the laboratory.
David Stokes (Principal Consultant and Director, Convalido Consulting Ltd, Newcastle-Upon-Tyne, UK)
David Stokes has been involved in computer systems validation and data integrity for more than thirty years, beginning with early FDA inspections of computer systems and data integrity in Europe in the 1980s. In the last thirty years David has worked for a number of international consultancies, providing strategic consulting services on a worldwide basis to a variety of pharmaceutical, medical devices and supplier organisations. He now leads his own small consulting practice as Principal Consultant and Director of Convalido Consulting Ltd.
He has had a long involvement with ISPE GAMP, is currently a member of the ISPE GAMP UK Steering Committee and has contributed to the development and industry review of the GAMP Guide and good practice guides. He has published a number of books on computer systems validation, most recently contributing to “Assuring Data Integrity for Life Sciences”, published by the Parenteral Drug Association.
Register now and learn how to assure data integrity in your laboratory