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.

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