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Mark Goodwin

GlaxoSmithKline, UK

Mark Goodwin is Director of UK Laboratory QA at GlaxoSmithKline. Mark is responsible for the UK GLP Quality Assurance programme and the GCP Clinical Laboratory QA programme. He also manages a team of auditors and provides consultancy to the business.

Mark has worked in GLP QA for 35 years and gained experience at Life Science Research, Smith Kline & French Research and Glaxo.

Mark was a founder member of the RQA GLP Committee and is the current Chairman of the Committee (third term as Chairman). He currently represents RQA at MHRA GLP Consultative Committee meetings and on the OECD GLP Discussion Group. Mark was a stakeholder during development of the MHRA risk based inspection strategy. He was an industry representative at the OECD Consensus Workshop on Multi-site Studies and participated in the 2008 OECD GLP Event at which Monitoring Authorities, Receiving Authorities and Test Facilities presented topics of GLP interest.

Lesley Graham

AstraZeneca

Lesley Graham After almost 17 years working for the MHRA as Lead Senior Inspector Lesley has recently taken up a post at AstraZeneca in their Global QA group.  During her time at the MHRA Lesley conducted inspections across several of the GXPs namely GLP, GCP and GMP of contract laboratories and investigational medicinal product sites. Lesley represented the UK at global regulator meetings such as the OECD and the EU GLP working party meetings; Lesley took the lead on the recent OECD GLP publication on Test Item and was part of the UK team leading on Data Integrity at OECD.  Lesley was regularly involved in training other inspectors in GLP and GMP Quality Control Laboratories; she did this at both a local UK and Global level.  As well as being part of the UK Good Laboratory Practice Monitoring Authority, Lesley was also responsible for setting up the routine programme of inspections of UK GMP contract quality control laboratories. Lesley spent the very early years of her career working in the quality control labs at a Boots manufacturing facility, then in a research lab at Strathclyde University. After graduating in 1994 as an analytical chemist she joined the pharmaceutical industry. Working initially as an analyst in the quality control laboratory then as a supervisor within manufacturing, here she was responsible for the manufacture of simple solutions and suspensions used in pre-clinical studies, to the more complex formulated products used in clinical trials through to scale up and production of large phase III, comparator and commercial products. It was during her time in the pharmaceutical industry Lesley first gained experienced of working to both GLP and GMP.

Paul Davidson

Headway Quality Evolution

Paul founded Headway Quality Evolution, a quality consultancy firm, in 2013.  Since then he has continued to curate a small team of experienced quality professionals offering services across non-regulated research, the GxPs and ISO standards.  He has been a member of the RQA GLP committee since 2011, is chair of the RQA Scotland Regional Forum committee, and is a member of the RQA North England Regional Forum committee.  Prior to HeadwayQE, Paul’s entire career had been focussed in academic or commercial research environments, therefore bringing 14 years’ experience of GLP quality assurance to the workshop.

 


Abstract

Regulators expect Quality Assurance to have access to and be able to review the raw data irrespective of whether it is paper or electronic. The anticipated OECD Advisory Document on Data Integrity is likely to include expectations on the review of raw data, audit trails and metadata and these will be aligned to the MHRA’s published guidance.

Industry is dealing with the challenges in identifying the extent to which their systems and processes comply with the regulatory expectations around data integrity. The outcome of their gap analysis is likely to have identified the need for remediation in the monitoring activities of some QA Units. QA Units may be at different stages of implementation or making enhancements to the initial integration of this expectation into their processes. 

This workshop will explore approaches to the QA monitoring of data integrity aspects through the delegates and facilitators sharing their experiences.  Discussions will centre around questions such as:

  • Do you know where to start?
  • Paper data or electronic data?
  • How do you audit an audit trail? 
  • How much access do you have to systems?
  • Do you know where to focus your attention?
  • Where is the line between QA and QC?

At the end of the session, delegates should gain an insight into how their approach compares with others and whether they are on track with implementation of their approach. Possible enhancements to current QA processes could be triggered from the practical approaches discussed. 

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