Tag Archives: Vaisala

Paul Daniel, Senior Regulatory Expert, VAISALA

Paul Daniel, Senior Regulatory Expert at Vaisala, has over 19 years of validation experience in the pharmaceutical and medical device industries.

Paul has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network, and computer validation, and extensive practical grounding in applying the good manufacturing practices principles of the FDA 21 CFR Parts 11, 210, 211, and 820.

An expert in authoring and executing validation protocols for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines. Paul holds a bachelor’s degree in biology (with honors) from the University of California, Berkeley.

What is your favourite thing about presenting on webinars?

It is an opportunity for me to give something back to the professional Life Science community which has given me a rewarding career in Validation.

What are you looking forward to explaining to the audience?

Mean Kinetic Temperature (MKT) is a really interesting topic. There is a deep and engaging story in the history of MKT that is intertwined with the history of HVAC and monitoring technology, and heavily influenced by ongoing regulatory changes in Good Distribution Practice. I am looking forward to sharing this story, so that we can see how our understanding and use of MKT has changed over the last 40 years, and hopefully, have a better idea of where this unique tool can be used effectively today.

What attracted you to the industry and what do you enjoy most about working at VAISALA?

I became involved in Pharmaceutical Validation because I was good with details, and I was seeking an industry where my work would have a direct link to improving quality of life. I joined Vaisala over 4 years ago because I thought it would allow me to be more effective at influencing positive change within my industry. I really like Vaisala because this company is dedicated to making the world a better place, one measurement at a time. Our mission statement – Observations for a Better World – conveys this idea. And, I really enjoy working with excellent people, in an established international company, that continues to create technology that changes the world. I may work in the narrow niche of Temperature Monitoring for Pharmaceuticals and Medical Devices, but Vaisala is involved in a much wider scope of enterprise that includes weather, road safety, interplanetary exploration, and preserving cultural treasures. I can’t imagine a more exciting place to work!

What is your favourite holiday destination?

I don’t have a favourite. But if you gave me two-weeks off and an expense account, there are a few places you would likely find me; high in the Colorado mountains fly-fishing an isolated stream, riding a mountain bike on remote single-track trails in the Pyrenees, or asleep in the sun on a beach in Mexico.

How did you spend the Easter holiday?

Easter was spent with friends and family, enjoying the return of spring, sitting in the sun, and talking about our hopes for the coming year.

Join Vaisala’s webinar with Paul on “Mean Kinetic Temperature in GxP Environments”. Register here.

Steven Jiroutek, Business Development Manager, VAISALA

Steven Jirsteveeeeoutek is the Business Development Manager for Industrial Applications at Vaisala, Americas. With over 12 years of experience at Vaisala, he oversees the business and strategy development for targeted industrial applications with specific focus on condition based monitoring of high voltage assets. He is responsible for identifying strategic partnerships and defining the measurement, technology and product needs of the markets. Steve holds a Bachelor of Science degree in Chemical Engineering from the University of New Hampshire.


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

Vaisala has always been an innovation and technology driven company with a strong customer focus.  We work closely with many pilot customers in order to help us bring new products to market.  In this process we discover new insights and best practices and are always looking for new ways to share our latest findings with other industry experts.

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

The concept of moisture movement within transformers is pretty well known in the industry however what’s less understood are the finer points related to how it happens, what it means, and how it’s measured.  I really enjoy taking a complex, confusing topic and helping to bring clarity to it by presenting new ideas and perspectives to a diverse audience.

  1. How did you get into the industry and what do you most enjoy about your role?

My background in chemical engineering served me well in understanding gas and liquid measurement applications however I knew from a very early point in my career that the “traditional engineer” role wasn’t going to suit me.  I moved pretty quickly to being on the front lines of business development and engaging with market leaders about new technologies & trends and applying that information to product development – this was a much better fit for my personality and interests.

  1. What are you hoping to achieve in the future in your personal and professional life?

The most important thing for me now and in the future is to always maintain the proper balance of time with my family and work that is meaningful and challenging to me.

  1. How do you relax in your leisure time?

The best way for me to recharge my batteries is to be active in nature – I’m an avid skier, hiker, backpacker, runner, and mountain biker.

Join Vaisala’s webinar with Steven on “Moisture in Transformer Oil Behavior” . Register here.

Piritta Maunu, Life Science Regulatory Expert, Vaisala

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.