Louise Mawer

GXP Auditor and Trainer
Mirabilitas Ltd, UK
Louise is a quality assurance auditor and trainer with extensive experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and, more recently, Good Pharmacovigilance Practice (GVP). She studied at Leicester Polytechnic (Science of Medicinal & Cosmetic products) and The Open University (BSc Honours). Working initially in inhalation formulations research and development, Louise moved into Quality Assurance in 1995, where she was employed by a UK Phase I unit with responsibility for overseeing Study GCP compliance. She left Leicester to move to Harrogate, North Yorkshire, and a large Contract Research Organisation, working in the field of GLP. Following 10 years as an auditor, Louise joined the UK Medicines and Healthcare Products Regulatory Agency (MHRA), as a GCP Inspector where she cross-trained as a GLP Monitoring Authority (GLPMA) Inspector. An active participant at the European Medicines Agency (EMA) GCP Inspectors Working Group, Louise supported the development of guidance on risk-adapted clinical trial methodologies, bioequivalence and clinical laboratory inspections, and GCP for Advanced Therapy Medicinal Products. Louise also participated in joint working with US FDA Investigators for GCP and contributed to Clinical Trial Transformation Initiative meetings. She currently provides Quality Assurance and training support to those involved in pharmaceutical development, including pharmaceutical companies, biotech companies and those in the non-commercial sector. She is the Chair of the Auditors’ Working Party for the European Forum for GCP and is a member of The Research Quality Association, supporting both the Northern Regional Forum and the Research Practice Group.
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Bioassays & Bioanalytical Methods
16. - 18. March 2022
Online Live Stream | 13:30 - 17:30 CET
Gas Chromatography in Oil and Gas Industry
8. - 10. March 2022
Online Live Stream | 08:45 - 16:00 CET
Biofuels and Alternative Fuel Sources
29. - 31. March 2022
Online Live Stream | 08:45 - 16:00 CET
Well Plugging and Abandonment Training
8. - 11. March 2022
Online Live | 12:45 – 18:00 CET
HSE Excellence Europe
11. - 12. May 2022
Amsterdam, The Netherlands
HSE,
Effective Corrosion Control for Process Industries
9. - 11. March 2022
Amsterdam | Online Live
Agility in Compliance - Yes, Please!
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Imploded Storage Tank
CONTRIBUTOR What Happened? After cleaning with steam a tank was quenched with cold water to shorten...
Importance of a mobile banking app within a bank’s multi-channel strategy
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Digital Banking: The Operational Backbone
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Queens of safety inventions
Throughout history, women were underestimated and it was unbelievable for society if a woman came up with...
EHS Opportunities due to COVID-19 – seizing the “new normal”
CONTRIBUTOR On March 11, 2020, the World Health Organization officially declared the novel coronavirus a pandemic....
Madelon Jansen
International Sales Development Manager
DriveTech
DI(FH) Rainer Fedra
VelaLabs, Austria
Dr. Florian Cymer
F. Hoffmann-La Roche Ltd., Switzerland
Dr Sandra Telen
Louise Mawer
GXP Auditor and Trainer
Mirabilitas Ltd, UK
Dr. Paolo Rossato
Associate Director, PK & QSP Unit, Pharmacology & Toxicology Department, Research
CSL Behring, Germany
Louise Mawer
GXP Auditor and Trainer
Mirabilitas Ltd, UK
Louise is a quality assurance auditor and trainer with extensive experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and, more recently, Good Pharmacovigilance Practice (GVP). She studied at Leicester Polytechnic (Science of Medicinal & Cosmetic products) and The Open University (BSc Honours). Working initially in inhalation formulations research and development, Louise moved into Quality Assurance in 1995, where she was employed by a UK Phase I unit with responsibility for overseeing Study GCP compliance. She left Leicester to move to Harrogate, North Yorkshire, and a large Contract Research Organisation, working in the field of GLP. Following 10 years as an auditor, Louise joined the UK Medicines and Healthcare Products Regulatory Agency (MHRA), as a GCP Inspector where she cross-trained as a GLP Monitoring Authority (GLPMA) Inspector. An active participant at the European Medicines Agency (EMA) GCP Inspectors Working Group, Louise supported the development of guidance on risk-adapted clinical trial methodologies, bioequivalence and clinical laboratory inspections, and GCP for Advanced Therapy Medicinal Products. Louise also participated in joint working with US FDA Investigators for GCP and contributed to Clinical Trial Transformation Initiative meetings. She currently provides Quality Assurance and training support to those involved in pharmaceutical development, including pharmaceutical companies, biotech companies and those in the non-commercial sector. She is the Chair of the Auditors’ Working Party for the European Forum for GCP and is a member of The Research Quality Association, supporting both the Northern Regional Forum and the Research Practice Group.
Louise Mawer
Description
Bioassays & Bioanalytical Methods
16. - 18. March 2022
Online Live Stream | 13:30 - 17:30 CET
Gas Chromatography in Oil and Gas Industry
8. - 10. March 2022
Online Live Stream | 08:45 - 16:00 CET
Biofuels and Alternative Fuel Sources
29. - 31. March 2022
Online Live Stream | 08:45 - 16:00 CET
Well Plugging and Abandonment Training
8. - 11. March 2022
Online Live | 12:45 – 18:00 CET
HSE Excellence Europe
11. - 12. May 2022
Amsterdam, The Netherlands
HSE,
Effective Corrosion Control for Process Industries
9. - 11. March 2022
Amsterdam | Online Live
Agility in Compliance - Yes, Please!
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Imploded Storage Tank
CONTRIBUTOR What Happened? After cleaning with steam a tank was quenched with cold water to shorten...
Importance of a mobile banking app within a bank’s multi-channel strategy
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Digital Banking: The Operational Backbone
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Queens of safety inventions
Throughout history, women were underestimated and it was unbelievable for society if a woman came up with...
EHS Opportunities due to COVID-19 – seizing the “new normal”
CONTRIBUTOR On March 11, 2020, the World Health Organization officially declared the novel coronavirus a pandemic....
Madelon Jansen
International Sales Development Manager
DriveTech
DI(FH) Rainer Fedra
VelaLabs, Austria
Dr. Florian Cymer
F. Hoffmann-La Roche Ltd., Switzerland
Dr Sandra Telen
Louise Mawer
GXP Auditor and Trainer
Mirabilitas Ltd, UK
Dr. Paolo Rossato
Associate Director, PK & QSP Unit, Pharmacology & Toxicology Department, Research
CSL Behring, Germany