Pharma’s Problems with Data Integrity

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.

About the Presenter

Brian Nadel

Brian Nadel works with domestic and international clients on matters of FDA compliance and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceuticals (OTC, prescription and APIs). Mr. Nadel conducts quality based audits, mock-FDA inspections and inspection readiness audits to assess site compliance with applicable requirements and assists with FDA-483/Warning Letter remediation and responses as well as general quality system CAPAs. Mr. Nadel has been a consultant since 2012, with prior careers at both FDA and industry. Mr. Nadel was the Senior Director, US Quality & Compliance and GMPs at Sanofi-Aventis, and Senior Compliance Manager, Corporate Quality & Compliance, GMP Compliance Assessment at Forest Laboratories, Inc. Mr. Nadel also worked as a compliance officer and investigator at FDA’s Center for Drug Evaluation and Research.