Tag Archives: Validation

Guy Matthews, Market Development Manager – Parker

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A conversation with Guy Matthews – Market Development Manager at Parker

Guy Matthews has worked in the biopharm industry for the last 20 years starting his career as a Scientist at a well-known CMO in the UK before moving to more commercial roles.

During this time he has been involved in many projects implementing single-use technology in both upstream and downstream bioprocessing.

At Parker, Guy is focused on bringing Parker’s expertise in motion and control to bioprocessing to create robust solutions in single-use technology that enable customers to improve the quality and accessibility of biopharmaceuticals

BRW: What do you hope the audience will learn from this webinar?

I hope to demonstrate that the validation of a single-use system goes beyond the usual areas of discussion – design, pressure, extractables and leachables, flow rates etc. – and that the audience needs to be thinking about how an assembly is used across a supply chain. Finally I’d like to show the value Parker can bring to ensuring the solution is fit for purpose.

BRW: What discussions do you look forward to having with the audience?

I look forward to hearing what level of testing they think is appropriate and where the line is drawn between the vendor and the end user in terms of responsibility for that testing.

BRW: What do you enjoy most about your role? 

The role I am in gives me an opportunity to interact with a great many customer across our industry, from the Big Pharma household names at one end of the spectrum to the start ups at the other. I like working with the appropriate Parker technology to find a solution to the challenges they face. I really enjoy the challenge and take pride in the fact that the solutions we create working together with the customer ensure the supply of medicines and vaccines that have a positive impact on the world.

BRW:  How did you get into the industry?

I would love to say it was all planned out, but in all honesty it was a series of happy accidents.  I enjoyed Science at school had an interest in biology so I studied that at degree level. After graduation I  worked at a CMO as a Microbiologist for a number of years before moving in to various commercial roles. The experience I have gained has given me a very board understanding of bioprocessing with a focus on single-use technologies.

BRW: Where is your favourite place in the world and why?

The centre of York racecourse. York is my home town and if I am on the race course ( on a non race day)  it means I am walking the family dog, usually with one of my two teenage daughters. Trying to get a teenager to communicate with you can be a challenge,  but throw a walk and a dog in to the picture and suddenly  the dialogue moves from one word answers to a conversation.

Join Guy Matthews on 14th November for a webinar entitled ‘Is There a Gap in Your Process Validation?’ at 3PM London/10AM New York.

Register Here!

Mission Possible; Streamlining Label Validation

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For many years, validating labeling processes has felt like an impossible mission for global medical device manufacturers, and has in some ways become a major barrier to the deployment of new systems for the fear of lengthy testing cycles and spiraling costs. Yet Label Lifecycle Management (LLM) is a mission critical ‘must have’ for life sciences organization that need to streamline processes, reduce labeling errors and mitigate risk.

It’s understandable that companies are cautious of change. The medical market is risk adverse in its very nature, no one can afford mistakes that threaten patient safety. Yet the move to newer labeling processes and methodologies offers real business gain that would mitigate such risks. So it shouldn’t be if LLM should be implemented, but how.

GAMP V (Good Automated Manufacturing Practice) sets out five key concepts to help medical device companies reduce the escalating costs of validation and improve compliance whilst bringing greater efficiency. These key concepts are:

  • Product and process understanding
  • Lifecycle approach within a Quality Management System (QMS)
  • Scalable lifecycle activities
  • Science-based quality risk management
  • Leveraging supplier involvement

The latter concept, which encourages companies to take full advantage of supplier capabilities, is perhaps key. The guide advises that regulated companies should ‘maximize supplier involvement throughout the system lifecycle in order to leverage knowledge, experience and documentation, subject to satisfactory supplier investment’. It argues that suppliers could be well placed to help with requirements gathering, risk assessments and the creation of functional specifications, as well as system configuration, testing, support and maintenance.

The long-standing notion of ‘validation pain’ need no longer present a barrier to the introduction of LLM innovation. With the right supplier, validation is no longer an impossible mission, you too can transform your validation cycle to drive progress, productivity and profitability.

To discover more tips on how to make the validation process simpler, why not register for our webinar and download our free whitepaper ‘Validation Pain to Real Business Gain’

Piritta Maunu, Life Science Regulatory Expert, Vaisala

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Piritta MaunuPiritta Maunu is a Life Science Regulatory Expert in Vaisala. She has long experience in biotechnology, having worked in several quality management positions in R&D, quality and GMP production. Piritta holds a degree of M.Sc. (Cell Biology) and has studied teaching with a specialty in General Biology. In her role at Vaisala, she creates informational content for life science customers and provides application support to R&D teams creating solutions for monitoring critical environments. Additionally, she provides training through webinars and seminars to both internal groups at Vaisala and to industry contacts.

1. Why did you decide to do a webinar with Business Review Webinars?

Through webinars we want to share the vast amount of knowledge that Vaisala experts have about measurement and monitoring of regulated environments. Business Review Webinars have proven to be a good platform for reaching out to the different players in the life science industry.

2. What are you looking forward to explaining to the audience?

I will discuss the chain of actions you need to understand and perform when storing supplies and products in warehouses regulated by Good Distribution Practices (GDP). These regulations tell you to perform a mapping study before storing any products in the storage areas. However, they don’t necessarily give you any practical guidance. In the webinar we go through some reference documents explaining what should be done as part of a mapping study. I will also give some advice on how to select the locations of sensors or data loggers for a monitoring system, and how the changes in the Annex 15 affect your mapping qualification and monitoring system software validation work. And last but not least, I will discuss some simple risk assessment principles that should provide help in validation of a monitoring system software.

3. What do you most enjoy about your role?

I enjoy working as a regulatory expert and meeting professionals within the field of life science. As I also have a degree in teaching biology, I find teaching people new skills very rewarding.

4. What would someone be surprised to know about you?

I studied music before taking my degree in cellular biology and teaching. During that time I played traditional Finnish instrument called “kantele” (it is similar to zither) as well as harp. The musical conservatory was located quite far away from my home, so I used to drive there by motorbike. My friends called me the motorcycling harpist.

5. What do you do in your leisure time to relax?

I like sports, as well as hiking and observing the wonders of the nature. I also enjoy fishing and picking berries. As my kids play soccer, it is part of my leisure time as well – watching the games and travelling around the country for the tournaments.

Piritta will be presenting Vaisala’s webinar ‘The Impact of 2015 Revisions to EU GMP Annex 15 on GDP’ on the 25th June at 3pm London/10am New York. You can register for the webinar here.