Audits and inspections are powerful tools to provide assurance that research and development are being conducted according to requirements, whether these are academic, regulatory commercial or ethical.
This interactive and engaging course will provide you with an overview of the processes for planning, conducting, and reporting audits and inspections.
This course can be booked on an individual or group basis. For individuals wishing to book, please see our payment options below, or if you are interested in training for your organisation at a time of your choosing, please contact training@towermains.com.
“Thank you for such fantastic training. I learned so much and was really inspired by both teachers’ experience and knowledge. They both brought such great energy and a very positive attitude.”
“Excellent presenter. Clearly very experienced and shared his experiences very well.”
“The examples and stories were very interesting and made this training different from other GCP refresher trainings that just stick to reviewing GCP sections one by one.”
“Really lovely style, laidback, friendly, informative. Great tutor”
Andrew Waddell has more than forty years’ auditing experience to GLP, GCP, GMP, ISO9001, ISO17025, ISO14155 and related standards.
From 1980 to 1998 he was Head of Quality and Training at Inveresk Research International where he was responsible for introducing and developing their GLP, GCP, GMP and ISO9001 systems before working as a consultant and founding Tower Mains in 2001.
Before joining Inveresk Research Andrew taught and researched in Pathology in the University of Edinburgh’s Medical School (where he was a member of the team that performed the early work on apoptosis) and was the government’s Professional Adviser in Health Education for Scotland.
A regular presenter at events in Europe, Japan and the USA, he has wide experience of working with government and industry bodies and was an adviser to the OECD during the development of the original OECD Principles of Good Laboratory Practice. He is a former Director and Chairman of the Research Quality Association (RQA) from which he received their annual Award in 2006 for extended, outstanding services.
Memberships and voluntary roles:
Senior Member of the American Society of Quality,
Fellow of the Research Quality Association
Board member of the Scottish Lifesciences Association
He is also known to a wider audience as a former international football referee. In 2007 he was appointed to the Council of the Scottish Football Association and to its Professional Game Board in 2013.
Fiona Waddell RGN CSci
Director
Fiona worked for 6 years as a Research Technician in Molecular Biology before undertaking nurse training in the Royal Infirmary School of Nursing. After qualifying and working as a staff nurse for a year, Fiona returned to research as one of the first research nurses in Scotland. She worked on various clinical trials in pharmaceuticals, medical devices, non-regulated research and then focused on stroke research in the Neurosciences Trials Unit in Edinburgh. After 10 years of research and initiating and developing the Edinburgh Clinical Trials Course Fiona went into commercial research on medical devices with Ethicon Ltd (a Johnson & Johnson Company), working primarily on women’s health until she became a Director with Andrew (her husband) in Tower Mains Ltd.
Fiona is involved in training, consultancy and advice, inspection preparation, mentoring and general people development and management.
Rhona has been working in the pharmaceutical industry for over 25-years, initially in steriles QC microbiology before moving into pharmaceutical and medical device QA. She was promoted to Manager, Quality Assurance and Regulatory Affairs. She moved to a small start-up solid and liquid oral dose pharmaceutical manufacturing facility and as their QA Manager implemented global PQS’. Finally moving to a global CRO as the Manager, Quality Assurance Early Clinical Research at a phase I site before coming to Tower Mains as a Principal Associate.
Her wealth of experience encompasses quality management system; generation, implementation and monitoring for Good Manufacturing Practice, Good Distribution Practice, Good Clinical Practice, and Medical Devices.
For Tower Mains clients, Rhona provides unique specialisms in audit, training and advice on a broad range of GMP/ GCP / ISO topics and is the Subject Matter Expert on GMP/GDP and Medical Devices.
Memberships and voluntary roles:
Chartered Institute of Quality (CQI) Chartered Quality Professional (CQP)
Member of the Research Quality Association (RQA)
Former Chair of RQA Irish Regional Forum Committee
RQA Good Manufacturing Committee
Member of the Pharmaceutical Quality Group
When not in the office Rhona is most likely to be found hanging out with her two cats or the horde of strays she looks after in Northern Ireland, doing crafts or putting out the fires from her husband’s current barbequing obsession.
Shona Ross, BSc, MRQA
Head of QA / Director
Shona has been working in pre-clinical and clinical research since 2004 with various roles including responsibilities as Study Director and Responsible Scientist for preclinical and clinical bioanalytical studies. This included secondments in both Kansas, USA and Verona, Italy to transition studies and align department processes for an international CRO. Further industry experience comprises Immunology PCR laboratories and regulatory affairs for medical device design dossiers and technical files. In addition, she set up a dedicated data integrity group responsible for technical review of GMP documents and data in a global pharma company.
She joined Tower Mains in 2015 supporting pre-clinical facilities and clinical laboratories for commercial, not for profit and academic organisations. This includes the development of their own customised regulatory and non-regulatory quality systems and the provision of training in quality system implementation, GLP and GCP for laboratories.
For Tower Mains audit clients, Shona has conducted vendor and study audits of GLP facilities, GMP and GCP laboratories, worldwide.
Memberships and voluntary roles:
Member of the Research Quality Association (RQA)
RQA GLP Committee
When not working, Shona is often to be found at the theatre or the dance studio watching everything from classics to contemporary pieces and eagerly awaiting the next art festival to immerse herself in the amazing new works and ideas these support.
Nicole LeBlanc, MRQA
Senior Associate
Hailing from Canada, Nicole moved to Scotland in 2016 after graduating with Distinction from the University of Alberta in Canada with a BSc in Agriculture and a Major in Animal Science. Through her degree, she was able to take advantage of the exchange programs and was able to spend a year at Dundee University studying Economics. Beginning her career as an animal technician in 2017, Nicole moved into Pathology at a large global CRO before moving into the quality assurance department in 2019, where she worked her way up to Quality Assurance Auditor II.
Her experience covers conducting study audits and inspections according to GLP.
For Tower Mains, Nicole will be conducting audits of GxP labs on behalf of clients and supporting clients in quality activities.
Memberships and voluntary roles:
Member of the Research Quality Association (RQA)
Secretary on the RQA Animal and Veterinary Products Committee
When not working, Nicole enjoys walking around different parts of Scotland, cooking, and spending time with her cat.
Anna Lothian, BSc, MRQA
Senior Associate
With a first-class honours degree in Biomedical science from the University of Dundee and an industrial placement year at a medical devices company under her belt, Anna began her career in the medical device field, starting out as a lab technician and working towards a technical manager role in Research & Development. Through these roles she gained experience working in and managing labs adhering to ISO 13485 and working to GLP and GMP standards.
For Tower Mains, Anna will be preparing and delivering audits for GLP, GMP and GCP compliance, helping deliver internal and external training and assisting with analysis and improvement of research quality systems.
Memberships and voluntary roles:
Member of the Research Quality Association (RQA)
Member of the Royal Society of Biology.
When not in the office, she can be found playing with any (and all) dogs, attempting to maintain a gym membership, and more recently trying to recover former cello playing abilities.
Erin Bell, BSc
Associate
Erin graduated from the University of Glasgow with an honour’s degree in Microbiology, making trips to Africa throughout her studies to work with hospitals and small charities to train and help strengthen their outputs. From there, she started her scientific career as a lab technician in a veterinary serology lab before transitioning to a global CRO to work in human clinical trials. She progressed her way into a team lead position where she led technical development and troubleshooting, as well as developing and conducting training for her department and others. She has experience working with global, diverse teams in both her work and personal life.
For Tower Mains, Erin will be responsible for organising and managing our internal quality management systems and our internal and external training programmes. She will be working on a programme of new courses that we will roll out during 2023…
When not working, Erin enjoys running, spin classes and being outdoors (preferably in a warm country!).
Dr. Andrew Waddell, FRQA
Co-founder / Director
Andrew Waddell has more than forty years’ auditing experience to GLP, GCP, GMP, ISO9001, ISO17025, ISO14155 and related standards.
From 1980 to 1998 he was Head of Quality and Training at Inveresk Research International where he was responsible for introducing and developing their GLP, GCP, GMP and ISO9001 systems before founding Tower Mains in 2001.
Before joining Inveresk Research Andrew taught and researched in Pathology in the University of Edinburgh’s Medical School (where he was a member of the team that performed the early work on apoptosis) and was the government’s Professional Adviser in Health Education for Scotland.
A regular presenter at events in Europe, Japan and the USA, he has wide experience of working with government and industry bodies and was an adviser to the OECD during the development of the original OECD Principles of Good Laboratory Practice. He is a former Director and Chairman of the Research Quality Association (RQA) from which he received honorary Life Fellowship for extended outstanding services.
He is also known to a wider audience as a former international football referee. In 2007 he was appointed to the Council of the Scottish Football Association and to its Professional Game Board in 2013.
Fiona Waddell RGN CSci
Co-founder / Director
Fiona worked for 6 years as a Research Technician in Molecular Biology before undertaking nurse training in the Royal Infirmary School of Nursing. After qualifying and working as a staff nurse for a year, Fiona returned to research as one of the first research nurses in Scotland. She worked on various clinical trials in pharmaceuticals, medical devices, non-regulated research and then focused on stroke research in the Neurosciences Trials Unit in Edinburgh. After 10 years of research and initiating and developing the Edinburgh Clinical Trials Course Fiona went into commercial research on medical devices with Ethicon Ltd (a Johnson & Johnson Company), working primarily on women’s health until she became a Director with Andrew (her husband) in Tower Mains Ltd.
Fiona is involved in training, consultancy and advice, inspection preparation, mentoring and general people development and management.
Rhona has been working in the pharmaceutical industry for over 30-years, initially in steriles QC microbiology before moving into pharmaceutical and medical device QA. She was promoted to Manager, Quality Assurance and Regulatory Affairs. She moved to a small start-up solid and liquid oral dose pharmaceutical manufacturing facility and as their QA Manager implemented global PQS’. Finally moving to a global CRO as the Manager, Quality Assurance Early Clinical Research at a phase I site before coming to Tower Mains as a Principal Associate, and progressively through to her current position as Executive Director
Her wealth of experience encompasses quality management system; generation, implementation and monitoring for Good Manufacturing Practice, Good Distribution Practice, Good Clinical Practice, Good Clinical Laboratory Practice and Medical Devices.
For Tower Mains clients, Rhona provides unique specialisms in audit, training and advice on a broad range of GMP/ GCP / ISO topics and is the Subject Matter Expert on GCP/GMP/GDP and Medical Devices.
Memberships and voluntary roles:
Chartered Institute of Quality (CQI) Chartered Quality Professional (CQP)
Member of the Research Quality Association (RQA)
Member of the Pharmaceutical Quality Group
Former Chair of RQA Irish Regional Forum Committee
Former member RQA Good Manufacturing Committee
When not in the office Rhona is most likely to be found hanging out with her cat or the horde of strays she looks after in Northern Ireland, doing crafts or putting out the fires from her husband’s on-going barbequing obsession.
Shona Ross, BSc, MRQA
Head of QA / Director
Shona has been working in pre-clinical and clinical research since 2004 with various roles including responsibilities as Study Director and Responsible Scientist for preclinical and clinical bioanalytical studies. This included secondments in both Kansas, USA and Verona, Italy to transition studies and align department processes for an international CRO. Further industry experience comprises Immunology PCR laboratories and regulatory affairs for medical device design dossiers and technical files. In addition, she set up a dedicated data integrity group responsible for technical review of GMP documents and data in a global pharma company.
She joined Tower Mains in 2015 supporting pre-clinical facilities and clinical laboratories for commercial, not for profit and academic organisations. This includes the development of their own customised regulatory and non-regulatory quality systems and the provision of training in quality system implementation, GLP and GCP for laboratories.
For Tower Mains audit clients, Shona has conducted vendor and study audits of GLP facilities, GMP and GCP laboratories, worldwide.
Memberships and voluntary roles:
Member of the Research Quality Association (RQA)
RQA GLP Committee
When not working, Shona is often to be found at the theatre or the dance studio watching everything from classics to contemporary pieces and eagerly awaiting the next art festival to immerse herself in the amazing new works and ideas these support.
Rita Silvestre BSc (Hons), MSc, MRQA
Senior Associate
Rita has been involved in the life sciences arena since 2012, initially completing two master’s degrees in Molecular Parasitology and Vector Biology, and also Medical Biotechnology prior to moving into industry, with a CRO in Anatomical Pathology and before joining Tower Mains in 2018.
Her experience covers QMS management, including the design of simple small bespoke systems, and statistical evaluations for GLP, GCP and GMP
For Tower Mains, Rita supports our internal QMS and conducts routine audits of laboratory, data and reports for GLP, GMP and GCP compliance.
She speaks Portuguese and English
Memberships and voluntary roles:
Member of the Research Quality Association (RQA)
When not working, Rita enjoys experimenting with new culinary recipes and travelling to new places for their architecture and museums.
Lianne Roeling
Head of Operations / Director
Lianne joined Tower Mains in 2017 and brought with her over 19 years’ experience in finance, purchasing, and order management.
she manages operations, finance, marketing and events for the company,
In 2000 after working on cruise ships and travelling the world, Lianne settled in The Netherlands where she worked for 2 American companies and took on the role of Purchaser. In 2008, Lianne moved back to her native Edinburgh, and in 2010 started her own childminding business to work around her growing family.
Lianne speaks Dutch and English.
When not travelling the world for pleasure, Lianne will most likely be found in the great outdoors, climbing the many hills in and around Edinburgh with her family and dog.
Victoria Macleod, CIM
Senior Marketing & Operations Associate
Victoria joined our team in 2021 with a background in events, marketing, and clinical settings. She holds a degree in English, is a qualified journalist, and is currently pursuing a degree in TV to further enhance her media skills.
In her role, Victoria supports both marketing and operations, contributing to the development of the company’s marketing strategies and operational objectives. Additionally, she is developing an online training platform to keep professionals up-to-date and compliant with the latest industry standards.
Beyond Tower Mains, you will find Victoria in a yoga or reformer Pilates studio, hanging upside down in an aerial class, or exploring new places.
Judith O’Hagan, BMedSci, MRQA
Senior Associate
Judith joins us with over 20 years of experience in clinical research. After graduating with a degree in Biomedical Sciences, she began her career as a research and development scientist before moving into a Laboratory Technician role in 2001. From here, she was promoted to Team Leader before working her way up to Senior Manager. Judith has experience in laboratory operations, from testing specimens and reporting results to provision, qualification, and auditing of external vendors as required under the principles of GCP and GLP.
For Tower Mains, Judith will be conducting audits and supporting clients in the area of GCP.
Membership and voluntary roles:
Member of the Research Quality Association (RQA)
Any free time Judith has is taken up as secretary of her local community group, volunteering to help recruit stem cell donors and long walks with her two hyperactive spaniels.
Nicole Ainsworth, MRQA
Senior Associate
Hailing from Canada, Nicole moved to Scotland in 2016 after graduating with Distinction from the University of Alberta in Canada with a BSc in Agriculture and a Major in Animal Science. Through her degree, she was able to take advantage of the exchange programs and was able to spend a year at Dundee University studying Economics. Beginning her career as an animal technician in 2017, Nicole moved into Pathology at a large global CRO before moving into the quality assurance department in 2019.
Her experience covers conducting study audits and inspections according to GLP and GCP
For Tower Mains, Nicole will be conducting audits of GxP labs on behalf of clients and supporting clients in quality activities.
Memberships and voluntary roles:
Member of the Research Quality Association (RQA)
Member on the RQA Animal and Veterinary Products Committee
When not working, Nicole enjoys walking around different parts of Scotland, collecting parkruns, and spending time with her cat.
Rosemary Ichaba, MSc, fCMgr, MRQA
Senior Associate
Rosemary was introduced to QA after completing a Masters in Drug Discovery and Pharma management and from here she branched out into Project Management, working within a Global CRO for two and a half years. Following this, she became QA Facilitator/Auditor in a research organisation before joining Tower Mains as a Senior Associate in 2022. Her experience covers Quality Management Systems, Vendor Assessment, and GCP/GLP Audits.
For Tower Mains, Rosemary will be conducting routine audits primarily in GCP laboratories and supporting clients in quality activities.
Memberships and voluntary roles:
Member of the Research Quality Association (RQA)
Outside work, Rosemary is the CEO of Financial Support 4 Students (FSS-UK) CIC, where she helps students find financial support.
Anna Lothian, BSc, MRQA
Senior Associate
With a first-class honours degree in Biomedical science from the University of Dundee and an industrial placement year at a medical devices company under her belt, Anna began her career in the medical device field, starting out as a lab technician and working towards a technical manager role in Research & Development. Through these roles she gained experience working in and managing labs adhering to ISO 13485 and working to GLP and GMP standards.
For Tower Mains, Anna will be preparing and delivering audits for GLP, GMP and GCP compliance, helping deliver internal and external training and assisting with analysis and improvement of research quality systems.
Memberships and voluntary roles:
Member of the Research Quality Association (RQA)
Member of the Royal Society of Biology.
When not in the office, she can be found playing with any (and all) dogs, attempting to maintain a gym membership, and more recently trying to recover former cello playing abilities.
Erin Bell, BSc
Senior Associate
Erin graduated from the University of Glasgow with an honour’s degree in Microbiology, making trips to Africa throughout her studies to work with hospitals and small charities to train and help strengthen their outputs. From there, she started her scientific career as a lab technician in a veterinary serology lab before transitioning to a global CRO to work in human clinical trials. She progressed her way into a team lead position where she led technical development and troubleshooting, as well as developing and conducting training for her department and others. She has experience working with global, diverse teams in both her work and personal life.
For Tower Mains, Erin will be responsible for organising and managing our internal quality management systems and our internal and external training programmes.
When not working, Erin enjoys running, spin classes and being outdoors (preferably in a warm country!).
Stacey Harding, BSc (Hons), MRQA
Associate
After graduating from the University of Nottingham with a first-class honours degree in Neuroscience, Stacey began her career in research as a Clinical Trial Assistant in a Phase 1 Unit. This led to a transition into quality assurance, where she gained experience auditing for a global CRO with its own investigator sites. In addition to auditing, she has developed and delivered training on data recording in GxP environments.
For Tower Mains, Stacey will be conducting routine audits in GCP for investigator sites and CROs and supporting clients in quality activities.
Memberships and voluntary roles:
Member of the Research Quality Association (RQA)
Outside of work, Stacey enjoys staying active with regular runs, exploring the Peak District, and attending weekly spin classes.
