Kenneth Christie
VTS Consultants, Inc., USA
Title: Current FDA audit trends and most common cited drug GMP deficiencies
Biography
Biography: Kenneth Christie
Abstract
The audit approaches of the FDA have changed over the years based on the findings within industry during inspections. These changes have also been the result of attempts to streamline the audit procedure and to help achieve efficiencies in trying to audit the ever increasing number of new companies on top of those existing. Preparation is still the main factor to help assure a successful audit result, and by knowing what the most common deficiencies have been, companies have an opportunity to compare their own practices and correct them where applicable. This presentation will review current and past audit approaches by the FDA, the four types of inspections performed, the regulatory forms associated with all FDA audits, what data sources are used by the FDA in preparing for their audits, common areas of focus, issues associated with data integrity, five proposed categories of “operator error” that are looked at when revieiwing investigations that cite operator error as the probable cause and the top 10 most common cited drug GMP deficiencies for the last three years (2012-2014). Attendees will have the opportunity to ask questions and actual case studies will be used to highlight various points discussed.