Menu

Implementing a Robust Data Integrity Program

By Visited 1 times , 1 Visits today

Start Date: 2021-03-12
End Date: 2021-03-12
Time: 10:00 am to 1:00 pm

Phone: +1-888-717-2436

Location: 6201 America Center Drive Suite 240 San Jose, CA 95002, USA

Website

Get Direction View Large Map

Description

As regulators are focusing their inspection on data integrity, it is important that managers, supervisors and users in regulated GMP laboratories understand the issues relative to data integrity and implement robust programs to ensure compliance. This webinar will help you do that. Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during compliance inspections. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification within companies around the globe. The regulatory concern has been responded to by both domestic and foreign governing agencies with the FDA, EMA, MHRA, WHO, and PIC/S all having recently published data integrity standards and guidelines.

Registration Information

Click the link for registration or ticketing information:

Registration URL

Organizers

Organized by :  Complianceonline

About the Organizers :

This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems. It will cover the common problems from FDA 483 observations and warning letters and teach you how to avoid them.