Thursday 16th March 2017
Assuring data integrity; best practice
Royal Society of Chemistry, London
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

Speakers:
Steven Brown - Novartis
Dr Adrian Davis - Pfizer Worldwide R&D
Dean Harris - Envigo Ltd
Tracy Moore - MHRA
Dr Gerhard Noelken - Data4Lab Ltd
Paul Smith - Agilent
Mark Stevens - Formpipe Life Science

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EXHIBITOR - BUTTERWORTH LABORATORIES

Butterworth Laboratories Ltd are a UK based contract laboratory providing analytical chemistry services to the global pharmaceutical industry in support of R&D, Clinical Development and Licensed Manufacture. We are GLP, GCP and GMP compliant and FDA & MHRA inspected.

We have extensive experience in the analysis of raw materials, finished products, devices and packaging in accordance with internationally published (EP, BP, USP, JP, JPE), client supplied or in-house developed methods.

A wide range of state-of-the-art analytical instrumentation compliment our classical competencies, enabling us to provide the most up-to-date and cost effective analytical services.