Technical Writing Skills

Gerry is a self-motivated medical industry professional with knowledge and experience of remediation in the highly regulated medical device, pharmaceutical and biotechnology markets, in particular sterile products. Skilled in developing and implementing strategic remediation plans, for example those aimed at DHF completion and CAPA compliance, including completion of verification, validation and effectiveness actions. Gerry has an excellent track record in Quality Systems, Validation and Risk Management projects in Medical Industry projects. Recent projects have included; Design History File remediation, Risk Management according to ISO 14971, preparation and updating of pFMEA, dFMEA, Risk management Plans, Risk management reports, and change control optimisation for deviations. Gerry implements a hands on approach to problem solving, project development and remediation activities.

Ita Lafferty is a Trainer and Consultant with over 25 years experience working with equipment and software suppliers in the Life Sciences industries. Her skills in Equipment Validation and Project Management are allied to a strong commitment to Customer Service. Ita brings her many years experience in writing and reviewing technical documentation for equipment and software to the TWS (Technical Writing Skills) course. Her ability to see situations from the viewpoint of both the end-user and the supplier, is invaluable in helping learners to write from the viewpoint of the reader, in order to ensure that the message is clear. Ita worked for an MS Word Template supplier for 11 years and has a wealth of tips and tricks to help take the frustration out of using MS Word. Ita’s 15 years of yoga teaching have made her very aware that people learn in different ways which informs her tutoring, ensuring all learners are catered for. She enjoys working with people who have different skill sets to her own, being aware that learning is always a two-way street.

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.