Avoiding Pharmaceutical and Biopharmaceutical Data Integrity Problems

“In recent years,” states the Agency, “FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.” While a few of these situations may actually involve intentional fraud, others may occur where simply inadequate controls have been put into place to prevent data manipulation. Whether intentional or not, FDA views these situations as unacceptable. The primary objective of this 90-minute accredited online training course is to equip you with the necessary skills to identify, evaluate, and remedy potential Data Integrity problems in your organization. Additionally, you will learn how to present to the FDA that your CGMP data satisfy the ALCOA principles - Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate. Our training program will focus on a recently issued Draft Guidance for Industry by the FDA, which outlines the agency's latest perspective on this critical topic.