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What was your background prior to joining CDP?
I spent 16 years at a large international pharma company, working in various different departments — from drug product development through to combination device development.
What drew you to CDP?
I was looking for an organisation that would give me an opportunity to explore a wider range of projects across the medical industry and use my experience to have an impact on their success. I was also looking for the opportunity to work in other industries. CDP works across a number of industry sectors at all stages of the innovation process — from front-end research through to transfer to manufacturing. It seemed an excellent place to get involved with.
What’s your formal education and training background?
I have a degree in Applied Chemistry, I’m an APMP-certified project manager, auditor trained and GMP (Good Manufacturing Practice) experienced. To enable the development of drugs and devices into combination products, I developed and implemented a quality management system compliant with ISO 13485 for medical devices for a pharmaceutical organisation. I’ve also written several regulatory documents for product submission.
What are you working on at the moment?
Since the combination product ruling by the FDA (Food and Drug Administration), I’m doing a lot of remediation work, trying to bring existing/developing combination products up to standard for the requirements. Before the final rule was published by the FDA in 2013, there was no clear guidance on how to integrate medical and drug products quality systems e.g. historically an injection system would have been considered as a container closure system under GMP, with no appreciation for medical device quality system regulation. The recent FDA final guidance on Current Good Manufacturing Practice Requirements for Combination Products clarifies this even further.
What does a ‘senior quality specialist’ do?
I make sure that in relation to quality management systems and regulations, medical device and combination product systems are developed and underwritten appropriately. This ensures projects are designed to have the right documentation, testing and risk management, and comply with quality and regulatory guidelines.
How does what you do fit in with the process of developing new products and services at CDP?
I provide the foundation (especially when we’re working for the medical world) that supports all of the other technical ideas. Put another way, a solid regulatory and quality framework underneath a new technical innovation is integral. All the technical wizardry in the world won’t count for anything if the new product or device can’t make it to market due to it not meeting the required quality, materials or other standards. Quality and regulatory considerations play a role, therefore so do I, at all stages of innovation development at CDP. This is right from initial Phase 0, through to finalising products for manufacture, and post-launch into the marketplace, via post-market surveillance systems.
Do you recall what inspired you to take this career path?
It happened in an organic way. Coming from a scientific product development background (where quality is innate in the development process) the evolution into the combination product world was fairly seamless. I’ve been able to bring through those skills I used back when I was a bench analytical chemist through to what I do now. Now as I was then, I’m guided by ‘good scientific practice’. Most of the time I find that what I consider to be the ‘right’ way to achieve something, from a quality perspective, is supported by regulatory requirements.
In the medical device development/quality space are there any recent discoveries or future trends you’re watching for?
The upcoming changes to Medical Device Regulations (MDR) in Europe will have a large impact on scrutiny of medical devices and drug delivery.
What do you get up to in your spare time?
Most of my spare time is taken up entertaining my two young sons and I’m about to become a Scout leader. In the time remaining, I’m a wannabe triathlete. My pinnacle achievement so far has been the Alpe d’Huez triathlon in France. I’m also trying to learn the acoustic guitar.
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