Jennifer Ahearn and Daniel Spankie lead Post Conference Tutorial on ‘Internal Data Auditing’ at 2018 GMP Conference at UGA!
The Regulatory team attended the 42nd International Good Manufacturing Practices Conference held at the University of Georgia March 12-15, 2018. The conference is co-sponsored by the FDA and the UGA College of Pharmacy. Speakers include FDA officials, international regulatory agency officials and experts from industry, all speaking on current trends in the Pharmaceutical Industry. Jennifer Ahearn and Dan Spankie hosted the post-conference tutorial on Internal Data Integrity Auditing where the following points were discussed:
– How the principles of ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) would apply to specific lab systems such as Chromatography Data Systems (CDS), Laboratory Information Management System LIMS, and stand-alone analytical systems. What types of flags to look for in your electronic systems.
– Considerations for data integrity auditing of paper based systems.
– SOP recommendations for routine data auditing based on the FDA’s Data Integrity and Compliance with CGMP Guidance for Industry April 2016 Draft Guidance.
– Company culture and its’ impact on data integrity with recommendations for data governance polices.
– Data Integrity considerations for manufacturing controls and automated systems.