Lesley has been working as a Lead Senior Inspector with the MHRA for the past 16 years. During this time she has conducted inspections across several of the GXPs namely GLP, GCP and GMP of contract laboratories and investigational medicinal product sites. Lesley represents 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 is part of the UK team leading on Data Integrity at OECD. Lesley is regularly involved in training other inspectors in GLP and GMP Quality Control Laboratories; she does 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 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.

Chris Gray is an Operations Manager within GMP and a senior inspector within. Having joined MHRA in 2007 as a GLP inspector she was cross-trained to inspect laboratories working to GMP and took up a management role within the GMP Inspectorate in October 2014. In addition to managing a team of inspectors, Chris continues to conduct inspections of laboratories working to both GLP and GMP. Prior to joining the agency Chris held a variety of positions in her 13 years in industry including working as a GLP Study Director in 2 large UK CROs, and 6.5 years working as an analytical chemist within DEFRA.

Michael has a Bachelors degree in Chemistry from the University of the West of Scotland. Michael joined the Medicines and Healthcare products Regulatory Agency (MHRA) in May 2015 as a GLP & GCP Inspector within the laboratories inspection team having worked for 5 years in a Quality Assurance (QA) organisation. During these 5 years Michael worked with a range of organisations including GLP programme members who conducted a variety of test types and laboratories involved in conducting clinical trial sample analysis. In his role at the Agency, Michael conducts clinical laboratory inspections, GLP compliance monitoring inspections and overseas inspections of organisations conducting bioequivalence studies.

Martin joined the agency in June 2015 as a GLP Inspector within the laboratories inspection team having worked for 7 years in contract research organisations. During these 7 years he built up experience of working in GLP compliant facilities as well as conducting clinical trial sample analysis. He has a Batchelor's degree in Biochemistry from the University of Newcastle.

Stephen is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also worked in the manufacturing sector and is a Chartered Chemist and Chartered Quality Professional. In his role as an Inspector, Stephen conducts GCP and GLP inspections of commercial organisations and laboratories in the UK in addition to inspection of overseas facilities as part of the MHRA inspection programme for organisations conducting Bioequivalence studies.

Jason joined the MHRA in November 2006 as a GCP Inspector and became a Senior Inspector in 2015 conducting a variety of inspections including GCP inspections of sponsors, CROs and laboratories, bioequivalence trials and GLP inspections. Jason has a split role between the GCP and laboratories inspection teams within the MHRA. Jason has a BSc (hons) in Biomedical Science and a Postgraduate Diploma in Pharmaceutical Technology & Quality Assurance (PTQA). Previously Jason spent seven years in the NHS working in hospital pharmacy (including clinical trials and manufacturing).

Emma Whale is a Senior GCP and GLP Inspector for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in July 2008, Emma worked for eight years as a GLP Auditor and Deputy GLP Quality Manager with experience in both Sponsor Organisations and Contract Research Organisations. Emma has also worked in histopathology for a large agrochemical company and she has an honours degree in Biomedical Sciences. In her role at the Agency, Emma conducts GCP inspections of both commercial and non-commercial organisations, phase 1 accreditation inspections, clinical laboratory inspections, GLP compliance monitoring inspections and overseas inspections of organisations conducting bioequivalence studies.

Lesley has been working as a Lead Senior Inspector with the MHRA for the past 16 years. During this time she has conducted inspections across several of the GXPs namely GLP, GCP and GMP of contract laboratories and investigational medicinal product sites. Lesley represents 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 is part of the UK team leading on Data Integrity at OECD. Lesley is regularly involved in training other inspectors in GLP and GMP Quality Control Laboratories; she does 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 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.

Chris Gray is an Operations Manager within GMP and a senior inspector within. Having joined MHRA in 2007 as a GLP inspector she was cross-trained to inspect laboratories working to GMP and took up a management role within the GMP Inspectorate in October 2014. In addition to managing a team of inspectors, Chris continues to conduct inspections of laboratories working to both GLP and GMP. Prior to joining the agency Chris held a variety of positions in her 13 years in industry including working as a GLP Study Director in 2 large UK CROs, and 6.5 years working as an analytical chemist within DEFRA.

Michael has a Bachelors degree in Chemistry from the University of the West of Scotland. Michael joined the Medicines and Healthcare products Regulatory Agency (MHRA) in May 2015 as a GLP & GCP Inspector within the laboratories inspection team having worked for 5 years in a Quality Assurance (QA) organisation. During these 5 years Michael worked with a range of organisations including GLP programme members who conducted a variety of test types and laboratories involved in conducting clinical trial sample analysis. In his role at the Agency, Michael conducts clinical laboratory inspections, GLP compliance monitoring inspections and overseas inspections of organisations conducting bioequivalence studies.

Martin joined the agency in June 2015 as a GLP Inspector within the laboratories inspection team having worked for 7 years in contract research organisations. During these 7 years he built up experience of working in GLP compliant facilities as well as conducting clinical trial sample analysis. He has a Batchelor's degree in Biochemistry from the University of Newcastle.

Stephen is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also worked in the manufacturing sector and is a Chartered Chemist and Chartered Quality Professional. In his role as an Inspector, Stephen conducts GCP and GLP inspections of commercial organisations and laboratories in the UK in addition to inspection of overseas facilities as part of the MHRA inspection programme for organisations conducting Bioequivalence studies.

Jason joined the MHRA in November 2006 as a GCP Inspector and became a Senior Inspector in 2015 conducting a variety of inspections including GCP inspections of sponsors, CROs and laboratories, bioequivalence trials and GLP inspections. Jason has a split role between the GCP and laboratories inspection teams within the MHRA. Jason has a BSc (hons) in Biomedical Science and a Postgraduate Diploma in Pharmaceutical Technology & Quality Assurance (PTQA). Previously Jason spent seven years in the NHS working in hospital pharmacy (including clinical trials and manufacturing).

Emma Whale is a Senior GCP and GLP Inspector for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in July 2008, Emma worked for eight years as a GLP Auditor and Deputy GLP Quality Manager with experience in both Sponsor Organisations and Contract Research Organisations. Emma has also worked in histopathology for a large agrochemical company and she has an honours degree in Biomedical Sciences. In her role at the Agency, Emma conducts GCP inspections of both commercial and non-commercial organisations, phase 1 accreditation inspections, clinical laboratory inspections, GLP compliance monitoring inspections and overseas inspections of organisations conducting bioequivalence studies.