Laboratory Software Validation

Carmel McCrea Kelly, BSc in Quality Management & Technology, Cert Manufacturing Engineering, Training & Continuing Education & Dip Pollution Assessment and Control is a Quality professional with over 20 years experience in the Medical Device and Pharmaceutical industry.

Carmel joined SQT as a tutor in 2018 and continues to work as a Quality Management Consultant with Northridge Quality and Validation.  Carmel feels that by combining her consultancy work with training through SQT she is best placed to impart her vast knowledge and experience to those currently working in the industry.  Prior to joining SQT, Carmel spent six years as Head of QA and RA of Medical Device Manufacturing plant where some of her achievements were; gaining certification to ISO 13485: 2016 and 21 CFR Part 820 and gaining CE Mark certification for several active Medical Devices.

Carmel has extensive experience of carrying out software validation projects in the industry over many years and continues to assist companies with these types of projects today.  Carmel regards achieving compliance with the EU Medical Devices Regulations (MDR) and maintaining adherence to the Software Validation requirements of ISO 13485: 2016 as being some of the biggest challenges facing Medial Device companies today.

John Lafferty, B. Tech. in Manufacturing Technology, Six Sigma Black Belt, Cert. Training & Continuing Education, Cert. Quality Management, 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.

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