Stepping into the world of auditing for the first time is an exciting experience, but also an extremely daunting one. Whether you’re conducting audits in the realms of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), or Good Laboratory Practice (GLP), there is a great sense of responsibility, and this [...]
A QA Perspective on the Annual Tower Mains Get-Together At the end of last year, the Tower Mains team got together in Edinburgh for a festive evening of food, drinks, entertainment, and activities. However, as Quality Assurance professionals, we couldn’t help but evaluate the event through the lens of continuous [...]
What is a Quality System, and why have one? This is a common question... and a valid one! It’s easy to make things complicated but below, we break down this question in easy-to-understand terms. What is a Quality System? A Quality System is a structured and formalised approach that enables [...]
Meet the Team – Q&A with Associate Stacey Harding After earning a first-class honours degree in Neuroscience from the University of Nottingham, Stacey began her research career as a Clinical Trial Assistant in a Phase 1 Unit. She later transitioned into quality assurance, gaining experience auditing for a global CRO [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA updates Good laboratory practice (GLP) for safety tests on chemicals. On 19th August, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the list of current UK GLP compliance programme members. Click [...]
Summer in Edinburgh: Top Things to Do and See Summer in Edinburgh is nothing short of magical (even in the rain!). With its city skyline, its perfect mix of old and new, and its backdrop of rugged hills, it is without a doubt one of the most beautiful cities in [...]
Top tips for choosing the right QA consultancy There are many reasons why your organisation may be in the market for a QA consultancy – including growing your company or services, staffing challenges or backlogs – and while there is no shortage of consultancies available, it’s essential to find the [...]
Key Considerations for a Good Lab Investigation When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Before embarking on a career [...]
Katarina: Celebrating 10 years at Tower Mains Join us in celebrating a milestone as we honour Katarina Eghan, who is marking an incredible ten years with Tower Mains! Since joining our team in 2013, Katarina has made a huge impact on the company, bringing her expertise and dedication [...]
Happy World Book Day! Finding moments of tranquillity and self-care can sometimes feel like a luxury in a world filled with constant distractions and busy schedules. However, amidst the chaos of daily life, one timeless activity stands out: reading. Beyond its role as a source of entertainment or education, reading [...]
Inspection Readiness: Are you prepared? Inspections by regulatory authorities can have significant implications – failing one can lead to penalties, reputational damage, and the potential suspensions of operations, whilst a successful inspection can bolster confidence and assure the quality and safety of your products or services. Whether your inspection is [...]
Travel tips for auditors Travel is often a necessity rather than a luxury, and whilst it can be exciting, venturing into unfamiliar territories can also pose a challenge. To enhance your travel experience, below are a few travel tips to make your trips more productive and a little less stressful. [...]
Our Top Places to Visit in Scotland It’s summer and there’s no better time to explore Scotland! Summer is a time when the country comes to life, allowing visitors and locals to immerse themselves in its breathtaking scenery, festivals, heritage and, of course, its ‘liquid gold.’ From unravelling the rich [...]
Meet the Team - Q&A with Senior Associate Anna Lothian After graduating with a first-class honours degree in Biomedical Sciences from the University of Dundee, Anna began her career in the medical device field, starting as a lab technician and working towards a technical manager role in Research & Development [...]
Without a doubt, performing services on-site has its advantages, for example, on-site audits allow the auditor to examine processes in real-time, complete in-person facility tours and interviews, and observe non-verbal communication, and training courses held in person tend to be more interactive. However, with technological advances, training, audit, and consultancy [...]
How to Create a Comfortable Working Environment as an Auditor Almost everyone within the working environment experiences the sudden audit notification and is automatically thrown into a mental frenzy of questions... Why are they coming? What will they be observing? And why now? These may be among a few questions [...]
Meet the Team - Q&A with Training Associate Erin Bell After graduating with an honour’s degree in Microbiology, Erin began her scientific career as a lab technician in a veterinary serology laboratory before transitioning to a global CRO to work in human clinical trials. From here, she progressed her way [...]
Meet the Team – Q&A with Senior Associate Rosemary Ichaba 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 [...]
Happy World Book Day! Did you know that reading for as little as six minutes per day can reduce stress by as much as 68%? Reading has some amazing health benefits, including improving your mental acuity, helping with anxiety, relieving stress, and lowering the chances of developing Alzheimer’s later in [...]
Happy Burns Day! It’s the 25th of January, the day we pay tribute to the life and work of Scotland’s ‘national bard’, Robert Burns. The first Burns supper is thought to have taken place over 200 years ago in 1801, where nine acquaintances of the late poet came together to [...]
Have you identified your QA support needs for 2023? Are you thinking about your upcoming audit schedule for 2023? Are you yet to identify your QA support needs? Ask yourself the following questions... ✅ Are you using your risk assessment? ✅ Do you have your audit plan in place? ✅ [...]
Happy St Andrew's Day For Scottish people all over the world, St Andrew’s Day – also known as ‘Andermas’ or ‘the Feast of Saint Andrew’ – is a time to think of home, celebrate and feast with friends old and new, across the world. But who is Scotland’s patron saint, [...]
Tower Mains is delighted to be attending the Research Quality Association (RQA) RE:UNITED International Conference! Don’t miss our Head of Quality Assurance Shona Ross who will be taking part in the below sessions: ✅ GLP – Audit Findings and Responses at 2pm, Wednesday ✅ GLP/GCLP Question Time at 2pm, Thursday [...]
Meet the Team – Q&A Rhona McAteer, Senior Associate Director Tower Mains’ longest-serving team member, 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 where she was promoted to Manager, Quality Assurance and Regulatory [...]
Meet the Team - Q&A with Nicole LeBlanc QA Associate Hailing from Canada, Nicole moved to Scotland in 2016 after graduating from the University of Alberta with a BSc in Agriculture and a Major in Animal Science. She began her career as an animal technician in 2017 before moving to [...]
Meet the Team – Q&A with Katarina Eghan, Director of TMQA Central Europe Having joined in 2013, Katarina is one of Tower Mains’ longest-serving team members. With over 14 years of experience in GCP and GMP, she began her career as a Pharmacy Technician/Production Manager in an early-phase research unit [...]
Making Cloud-Based Services Less Cloudy When selecting a cloud-based service provider (CSP), it is vital to assess the reliability and capability of the provider that you plan to entrust with your organisation’s data. Finding the right fit for your organisation is essential. Here, are a few things to consider when [...]
Meet the Team – Q&A with Senior Associate Judith O’Hagan With over 20 years of experience within clinical research – initially as a research and development scientist before moving her way up to Senior Laboratory Manager – Judith joined Tower Mains in 2021 as a Senior Associate. Here, she tells [...]
MHRA Compliance Monitoring Scheme: Step in the right direction or first on a slippery slope? From April 2022, the MHRA will begin a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM) to reduce the significant burden on the agency resources by the [...]
Here at Tower Mains, our objective is to bring you first-class training that meets your needs and allows you to understand the complexities of regulations, guidance and inspector expectations. Every quarter, we provide our ‘standard’ training which consists of: Introduction to GLP GLP Refresher Introduction to GCP GCP Refresher Each [...]
Meet the Team – Q&A with QA Associate, Rita Silvestre Rita has been involved in the life sciences arena since 2012, initially completing two master’s degrees in Molecular Parasitology and Vector Biology, and Medical Biotechnology before moving into industry with a CRO, then joining Tower Mains in 2018. Here, she [...]
Happy World Book Day! Did you know that reading for just six minutes a day reduces stress by a huge 68%? Reading not only expands our general knowledge, but it’s also a great memory exercise, can increase our emotional intelligence, and can help people lead more peaceful lives. Plus, reading [...]
You may have come across the following statements in the MHRA GCP Inspection Metrics reports as part of the observations surrounding critical findings: ‘…There was no process in place to ensure…,’ ‘…were not defined in the SOP nor was there any clear policy and process to ensure…,’ ‘There was no [...]
Meet the Team – Q&A with our Head of QA, Shona Ross After working in various roles in pre-clinical and clinical research – including Study Director and Responsible Scientist for bioanalytical studies – Shona joined us in 2015 as an Associate. Since then, she has taken on several senior roles, [...]
Meet the Team - Q&A with our Director, Andrew Waddell With over forty years in the industry, including almost twenty as Director at Tower Mains, Andrew Waddell talks us through his career highlights and lowlights, tips on how to succeed in QA, and what makes him tick outside of Tower [...]
Q&A with Rhona McAteer, our GMP Expert Looking for expert advice on Good Manufacturing Practice (GMP)? Look no further! With over 25 years in the pharmaceutical industry – initially in steriles QC microbiology before moving into pharmaceutical and medical device QA – Rhona McAteer, our Associate Director and GMP expert, [...]
For almost twenty years, Tower Mains has been proud to offer and provide international audit, consultancy, and training services. With over 200 years of global regulatory experience, our diverse team is on hand to offer flexible, credible, and cost-effective quality assurance support services – from short ad hoc projects to [...]
Our objective is to bring you first-class training that meets your needs and allows you to understand the complexities of regulations, guidance and inspector expectations. Each course is led by an expert in the field, and they use their experience and expertise to bring their topic alive with information, and [...]
The '5C' approach to QMS The QMS is more than just a list of documented procedures and processes. It links to every facet of your organisation’s performance no matter how big or small you are, therefore driving a quality culture throughout and ensuring everyone is responsible for quality. It’s organic, [...]
Implementation of ISO9001:2015 QMS can be daunting and confusing. Here at Tower Mains, we have put together a simple yet effective infographic that explains; the 7 Quality Management principles, the 9001 approach, the PDCA Cycle, and how the clauses of the standard align to the PDCA cycle and, of course, links [...]
Many challenges face the multicultural auditor today… Which is why our Director Andrew Waddell chose to shed some light on the topic at the #RQA2020 International QA Conference on Tuesday. It certainly was a difficult topic to summarise in 25-minutes but, never one to shy away from a challenge, Andrew [...]
Tower Mains is pleased to announce training courses to help you, your employees and colleagues stay up to date with the latest practices, standards and guidelines are now on our new website. We’ve been running training courses for many years. However, times change, expectations and requirements change, and we decided [...]
Who are we? Tower Mains Ltd was first established in 2001 as an independent Research Quality Assurance consultancy that became widely known as TMQA. Our core business was conducting audits for clinical trials, regulatory laboratories, pharmaceutical manufacturing, and other biotech industries. Our Tower Mains’ team has acquired a diverse set [...]
Tower Mains staff have experience of providing remote training to people and groups around the world. The benefits of groups working with experts “face to face” are well understood, especially the personal interactions such courses provide. This is not always possible or desirable when considering cost and environmental impact of [...]
