David Easton is director and principal validation consultant of Zener Engineering Services. His experience has been predominantly gained by working for world-class pharmaceutical and medical device manufacturers, as well as healthcare providers. Easton’s presentation will highlight and discuss a number of GMP project mishaps.
“The team at Zener Engineering Services (ZES) is looking forward to exhibiting at the Med-Tech Innovation Expo, our first time exhibiting at a trade event. My talk is entitled ‘Have You Ever Wondered Why a Project Was Not a Resounding Success, but Were Too Afraid to Ask?’
Benefitting from over 25 years’ experience of GMP project management of up to £20m, I decided to share those experiences and examine why some projects flounder.
There are an infinite number of scenarios which have the potential to produce a GMP project mishap, but most of these can be controlled to reduce risk. In floundering projects, we have found common problems and issues, which should be addressed to help towards project success.
David Easton
My presentation aims to address some of the most common GMP project issues and I expect that the audience, will find the illustrated examples very revealing.
ISO 13485:2016
With the publication of ISO 13485:2016, there is a realisation that the validation requirements for medical devices are more comprehensive and overall more akin to the detailed requirements of pharmaceutical manufacturing. Enquiries regarding software validation and cybersecurity, for example, are becoming more and more frequent.
Why You Should Choose ZES
We started as a small engineering company specialising in quality engineering, focused on pharmaceutical and medical device manufacturing compliance to FDA and MHRA regulatory requirements. Over the years, we have evolved into an all-round service provider and consultancy, dedicated to health and life sciences.
Founded on the principles of being innovative and providing world-class solutions, ZES is building a reputation for quality and excellence. Key personnel have worked in highly regulated industries, bringing a wealth of expertise to the service we provide. Members of our management team have substantial qualifications and experience in the sectors in which we operate.
Quality and reliability
We provide a first-class comprehensive engineering service, covering a range of pharmaceutical and medical device manufacturing operations, and healthcare provider services.
We provide a specialist engineering service for projects, maintenance and consultancy, enabling engineering tasks (large or small) to be outsourced to a single point of contact.
GMP quality and reliability are at the centre of everything we do.
Speed and flexibility
We provide speed and flexibility whilst responding to the changing needs of our clients, from small single drawings, to project management of large capital projects.
Our business model allows us to operate all over the UK and Europe, whilst being able to promptly deliver a first-class quality engineering service.
All aspects of pharmaceutical and medical device manufacturing are covered, to the highest of standards.
FDA / MHRA experience
ZES personnel have worked with former FDA inspectors and have fronted FDA and MHRA inspections. We have striven to ensure a successful inspection outcome. Inspection preparation and remediation are areas where we have significant experience.
Value for money
We deliver by utilising hands-on approaches, drawing on the professional experience of our consultants, to provide our customers with a flexible and value-for-money partner.
Through careful use of resources, we can deliver the same level of service as provided by much larger companies, more quickly, whilst delivering a better service. Our business model allows us to pass on savings.
Just GxP engineers
We only utilise GxP engineers who hold relevant qualifications and possess hands-on experience in engineering or science. Our clients also enjoy complimentary access to our senior management team, on an ad-hoc basis, during the engagement. All our engineers have proven experience.
We don’t utilise dedicated salespersons, recruitment agencies or other non-engineering bodies. We utilise our network of over 150 experienced GMP engineers.”