Good Laboratory Practice (ISO 17025:2017 QMS Requirements)

Anne Marie is an established Quality professional with over 20 years’ experience within the Life Science sector including 7 years as a quality manager where she managed quality, regulatory and health & safety management systems.

Anne Marie holds a BSc. (Hons) Degree in Environmental Health, Diploma in Manufacturing Management, Diploma in Industrial Studies, FETAC award in Process and Product validation, QQI special purpose award in Training, Development & Evaluation and Certificates in Quality Management & Statistical Techniques.

A strong and experienced auditor, Anne Marie has completed IRCA internal auditor training in 1996 and IRCA lead auditor training in 2004 and conducted extensive supplier audits across Europe and the US. Anne Marie regularly conducts gap, pre-assessment and internal audits for clients with standards and regulations such as ISO9001, ISO13485, ISO17025, MDSAP, GMP & FDA CFR 820.

Anne Marie completed her black belt training in 2011 and has gained extensive experience applying the techniques learned. Her background in quality management & statistical techniques enables her to support clients in quality control, validation, and estimation of measurement uncertainty.

Anne Marie is a powerful advocate for developing employee understanding of the end use of product manufactured or service provided and has previously endorsed World Quality Day with yearly events involving employees, customers, and suppliers. Anne Marie is passionate about learning and has an ability to make compliance subjects enjoyable with her collection of shared experiences. She has recently developed a new and unique training course on measurement uncertainty to meet the needs of SQT clients.

John Lafferty is a Quality professional with over 25 years experience in the medical device and pharmaceutical industry. John joined SQT as a tutor in 2007. Prior to that, John spent many years working in the Medical Devices/ Pharmaceutical sectors – the final six years of which were as a Senior Manager of a multinational Medical Devices plant where he managed the Quality and Regulatory Systems. John completed his Lean Six Sigma Black Belt training through SQT in 2009 and derives great benefit from applying the techniques that he learned to Risk Management and Validation in a Life Sciences setting. “It is great to be able to bring this knowledge, and the experience gained from ongoing involvement with Life Sciences companies, into the classroom,” he says.

John passionately believes that the key to success in Life Sciences Manufacturing is the relentless application of Risk Management, Variation Reduction and Good Validation Practices. As the SQT tutor for Technical Writing Skills, John believes that good written communication skills are vital for any Life Sciences professional.

John holds the following qualifications: a Bachelor of Technology in Manufacturing Technology, a Six Sigma Black Belt, a Certificate in Training & Continuing Education and a Certificate in Quality Management. John is a member of the following committees relating to Risk Management of Medical Devices; ISO TC 210 – Medical Devices Technical Committee and CEN/ISO JWG1 – Joint Working Group on Risk Management.

One of John’s greatest achievements, in recent years, has been the development of the MDSAP and MDSAP Internal Auditor courses in response to demand from SQT’s loyal client base.

Kevina takes great pride in the training she delivers. She understands that supporting you effectively means meeting challenges and deadlines, understanding your specific needs, communicating effectively with you and providing accurate and honest advice, with integrity and confidentiality.

Kevina is a PhD graduate from the National University of Ireland, Galway. Since graduating she has worked in the life science industry for 20 years, both nationally and internationally. Beginning in the diagnostics sector, working for Cambridge Diagnostics she then moved to the medical device sector working for Abbott Vascular, Galway. Here she worked as a Microbiologist and was closely involved in the setting up, validation and monitoring of cleanroom environments and evolved into the Quality and Regulatory areas of the Life Science Industry.

Kevina delivers training programmes on many different topics related to Auditing, CE Marking, Quality Standards, Cleanroom Controls and Behaviours, GMP, as well as developing bespoke training programmes to meet specific client’s needs. Kevina’s outstanding attribute is her ability to motivate learners and enable their learning through sharing her knowledge and work-based experiences, in a simple and easy to understand way thus allowing the learners to achieve their learning goals successfully.

In addition to providing expert training, Kevina routinely works as a consultant and auditor. Kevina has the expertise to deal effectively with both Cleanroom, Quality and Regulatory related issues. Kevina is knowledgeable in many different quality and regulatory standards within the medical device, pharmaceutical, laboratory, & healthcare industries, is a strong and experienced auditor consistently challenging systems for compliance in a fair and consistent manner. With the wealth of experience Kevina has accumulated to date working with many different companies, she can appreciate and identify many similar situations thus allowing her to link examples and communicate clearly and effectively to ensure understanding.

Kevina provides key support to both start up and multinational companies. She is an accomplished trainer with a Certificate in Training and Continuing Education from NUI, Maynooth and has also successfully completed QMS Auditor / Lead Auditor training.