Assuring Laboratory Data Integrity in a Time of Enhanced Regulatory Oversight

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.

This webinar will present on the topic of laboratory data integrity, examining this from the perspective of Laboratory Management, Supervisors and Technicians.

Topics covered will include:

• 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

• Intended Audience: Laboratory Data Owners (Managers) and Data Stewards (Laboratory Supervisors and Technicians).

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

Presenter: David Stokes (Principal Consultant and Director, Convalido Consulting Ltd, Newcastle-Upon-Tyne, UK)