By: John R. Godshalk, MSE, MBA, Senior Consultant
Data integrity has always played an essential role in regulatory application review and cGMP inspections – a trend that will only continue to grow in the coming years. The FDA’s April 2016 draft guidance document "Data Integrity and Compliance with cGMP” is an important step by the Agency to clarify its current thinking and policy regarding data integrity moving forward.
In this paper, John R. Godshalk chronicles the issues he has encountered with data integrity in pre-approval inspections and reflects on related points in the Agency’s April 2016 draft document. He also guides readers through common data integrity mishaps and provides useful tips and best practices for avoiding them.
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John R. Godshalk, MSE, MBA is a senior consultant at Biologics Consulting. Prior to joining the Biologics Consulting team in 2005, John served as a Senior Review Biochemical Engineer and Lead cGMP inspector for the Division of Manufacturing and Product Quality at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) for 3 ½ years.
With more than 15 years of experience in cGMP, regulatory affairs and management consulting, John assists clients with a wide range of cGMP and regulatory projects.