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Assuring data integrity; best practice
Location: Royal Society of Chemistry, Burlington House, Piccadilly, London W1J 0BA
Email: [email protected]
Data integrity is receiving much attention in the pharmaceutical industry, with several high profile cases where deficiencies have resulted in regulatory action, and the MHRA, FDA, EMA and WHO have all issued guidance documents recently.
These guidance documents draw together the requirements of predicate rules and point the industry towards better practices in the life-cycle management of data records, from initial validation of data management systems, through daily operations, to long-term retention and archival practices.
Although the scope is primarily support of GMP, the MHRA has recently drafted guidance for GLP, GDP and GCP, which applies the same standards across these related activities.
This symposium will bring together experts from Health Authorities, pharmaceutical companies, CROs and technology -providers to discuss the approaches being taken to rise to the challenge of increased scrutiny of data management practices. Particular focus will be given to the changes that need to be implemented, and to the consequences for a GMP manufacturing organisation if it does not assure data integrity.
Registration starts at 9.30 and the symposium starts at 10.00
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics