Data integrity in the GMP analytical laboratory continues to be THE major global topic amongst both regulatory agencies, pharmaceutical companies and suppliers. Although the headlines are still gabbed by warning letters and non-compliances involving cases of falsification and fraud from a minority of organisations this is the tip of the iceberg. The majority of data integrity issues seen in warning letters and 483 observations are still due to poor data management practices where records created are not adequately documented, electronic records that are poorly protected or not protected at all and / or there is still a reliance on paper printouts from computerised systems as raw data. Since 2015 there has been a tsunami of regulatory guidance and advice from MHRA, FDA, WHO, PIC/S, EMA and even the Chinese FDA. In addition, ECA have issued a draft guidance for comment and the April 2017 release of the GAMP guidance on Records and Data Integrity that is a companion to GAMP® 5. Do these guidances say the same things or are there contradictions? How should laboratories and suppliers respond to the WHO suggestion that „replacement of hybrid systems should be a priority“?
The second Laboratory Data Integrity conference is designed to present, from a practical perspective, the following areas:
Laboratory data integrity where are we now?
Regulator talk
Review of the GAMP Guide on Records and Data Integrity
Scope of the Second person review
Instruments with integrated software – quo vadis?
Data integrity audits
Data integrity from research to manufacturing
Developing metrics for laboratory data integrity
Using data flow mapping to identify data integrity concerns
Instrument Supplier’s perspective of data integrity
In addition, there will be a Discussion Forum at the end of day 1 where all delegates will have the opportunity to ask specific questions to benefit from the speakers’ experiences in this field.
Download pdf brochure at www.gmp-compliance.org
