Presented by Independent Consultant, Brian Nadel
FDA takes data Integrity very seriously and their many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years, indicate that validation is a consistent problem for the pharmaceutical industry. Data integrity, or lack thereof, can have major repercussions for a firm because once FDA finds some data to be unreliable, it considers all of a firms’ data to be unreliable. FDA expects that data to be reliable and accurate, and that crucial and often overlooked validation step can ultimately cost manufacturers untold amounts in R&D, materials, product recalls, submissions, and more.
Understand the Agency’s expectations of data integrity as well as how your company can assess your compliance. Learn critical strategies and processes that each firm should undertake to limit data integrity risk and demonstrate reliable data every time.