Articles by Barbara Unger

  1. What Recent FDA Enforcement Actions In The EU Mean For FDA/EMA Cooperation 10/6/2016

    FDA and the EU have taken serious enforcement actions against firms in the other’s geographic jurisdiction during the calendar year 2016. In the preceding article, we looked at European inspectorate actions against sites in the U.S. Issues identified as problematic included deficiencies in aseptic processing of parenteral drugs, data integrity concerns, lack of controls to prevent cross-contamination, and failure to adequately address observations from previous inspections. FDA had inspected each of the three facilities within the past year.

  2. An Analysis Of Recent CDER Observation & Warning Letter Data 7/1/2016

    The FDA publishes data on Form 483 inspection observations and warning letters issued by the Center for Drug Evaluation and Research (CDER) during the previous fiscal year. By analyzing this annual data pharmaceutical and biopharmaceutical manufacturers can gain a clearer picture of FDA enforcement trends and their potential impact on business.

  3. Tips For Identifying And Correcting Data Integrity Deficiencies In Your Organization 5/3/2016

    Often, the thought of addressing computer system issues and data integrity evaluations becomes overwhelming to quality personnel, and thus these responsibilities are deferred to members of the IT department. I intend to simplify this topic and share some straightforward actions that firms can take to identify and correct deficiencies.

  4. Data Integrity: Understanding Global Regulations & Past Enforcement Actions 4/1/2016

    In this article, we will address the regulations and guidance published in this area, and review data integrity-related enforcement actions taken over the past 10+ years.

  5. An Introduction To Data Integrity For GxP Regulated Firms 2/10/2016

    This article series intendeds to remove some of the mystery surrounding the topic and to provide readers a broad background on data management and data integrity — as well as suggestions for how they might begin to address this issue within their company.