Data Integrity in Pharmaceutical and Biotech Labs - 2-Day In-person Seminar

About this Conference

Course Description:

The subject of Data Integrity has become an increasing concern for Regulatory Agencies worldwide. We have seen a sharp increase in the number of Warning Letters by the FDA on this topic and the majority of the laboratory related warning letters issued in 2015 focused on this topic. The FDA has issued a draft guidance in April 2016 on Data Integrity which will have wide implications on how raw data, both electronic and paper, is to be generated, reviewed and archived. This seminar addresses the key elements of Regulatory Expectations for Data Integrity. Ten steps to achieving an efficient and cGMP compliant Data System will be discussed.
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Who will Benefit:

QC chemists, supervisors and managers
R&D chemists, supervisors and managers
QA managers and personnel
Regulatory affairs personnel