Lab Data Integrity, Part 2 - Self Inspections and Audits to Confirm Data Integrity
: 27 Jun 2019 - 28 Jun 2019
: Vienna, Austria
Following on from Lab Data Integrity, Part 1 Establishing the Controls for Ensuring Laboratory Data Integrity, Lab Data Integrity, Part 2 - Self Inspections and Audits to Confirm Data Integrity takes the principles from the earlier course and develops them to enable attendees to be able to conduct effective internal audits or self-inspections of either hybrid or electronic systems in compliance with EU GMP Chapter 9. This is achieved mainly via a series of interlinked workshops with a few presentations. This course will focus only on hybrid and electronic systems.
Data Integrity is currently the major concern with both the FDA and European Regulatory Agencies. Many FDA warning letters and EU GMP inspections have highlighted major data integrity failures at companies globally. This regulatory concern has resulted in the FDA issuing Compliance Program Guide (CPG) 7346.832 that covers Pre-Approval Inspections. This document became effective in May 2012 after Agency inspectors received training in data integrity with a focus on computer systems and not the paper output. The CPG objective 3 covers the laboratory data integrity audit. In April 2016 a draft data integrity guidance was issued for industry comment. In March 2015, MHRA issued an updated Data Integrity Guidance containing an expansion of the expectations of data integrity governance together with a list of 19 definitions and expectations for each one. Followed in July 2016 by a more general guidance for GXP data integrity. In June 2016, the World Heath Organisation issued a final version of a guidance document which provides a more encompassing explanation of data integrity and also data governance expectations for regulated healthcare companies. EMA and PIC/S both issued draft data integrity guidance documents in August 2016. ECA have published two versions of Data Governance and Data Integrity guidance in 2016 and 2018. The GAMP Forum have published a Guide on Records and Data Integrity in 2017 and the first of three Good Practice Guides on Data Integrity - Key Concepts. Lastly, PDA have also issued a guidance document for pharmaceutical laboratories in August 2018. The emphasis of all regulators is on the ALCOA principles to outline regulatory expectations for ways to ensure the integrity of data over the life cycle. This is reflected in the way the two courses will be presented.
Course 1 focuses on three types of record that can be found in analytical laboratories working to GMP: paper, hybrid computerized system and electronic workflows with electronic signatures. Through presentations, workshops and discussions attendees are taken through the process from analysis to generation of results to understand data integrity issues.
Course 2 takes the principles from the earlier course and develops them to enable attendees to be able to conduct effective internal audits or self-inspections of either hybrid or electronic systems in compliance with EU GMP Chapter 9.