Regulatory Round up - Plus new Q&A from our latest webinar on VaiNet Technology Janice Bennett-Livingston Published: May 2, 2017 Industrial Manufacturing and Processes Life Science This week we offer several items for your blog-reading pleasure: A link to our recent VaiNet Wireless monitoring webinar, recording, and slides Q&A from that webinar and we will continue to publish the answers to your questions as they continue to come in by email. Thank you for all this wonderful engagement! Links to upcoming regulatory changes from the FDA, EMA, Health Canada, China, and Japan... A link to a new webinar on CO2 measurement Part 1 of our Q&A from the VaiNet webinar Can the data points be fed up to a larger system via BACnet? The data points cannot be fed directly to BACnet. To import the data into a BACnet system, you would need to query the viewLinc database. This is not a usual feature, but we could work with you to develop it for your application. Contact our applications engineers. How does VaiNet compare with fiber? If I understand your question correctly, you are asking to compare the wireless VaiNet system against a fiber optic cable system. The two are quite different. Fiber optic cable is a fixed physical connection that has a lot more in common with Ethernet cabling. VaiNet is a wireless solution that requires minimal infrastructure and offers flexibility and easy install. If comparing data rates, fiber optic cable will have a much higher data rate, as VaiNet by design only handles the small packets associated with encrypted monitoring data. How big are the VaiNet transmitters? The RFL100 data loggers are compact - about twice the size of a pack of cigarettes. How much time between sensor measurement reporting? Such as in minutes, seconds or milliseconds...The sensors will take measurements every minute. The sensors will transmit their measurements to the viewLinc Server, via the AP-10, every 4 minutes. The average time between the time of the measurement and its appearance in the database is about 2 minutes. The AP10 can be used outdoor on tropical environments? The AP10 Access Point is designed for indoor use. When will the VaiNet RFL, AP10, viewLinc 5.0 become available for purchase and implementation? The release is planned for late 2017. Can we do an on-site study to see if we can replace WiFi routers? Sure. Let’s get together and install some devices at your site. Best to connect with one of our engineers. Do data loggers imply also sensors/transducers? Yes. The sensors are housed in a probe installed in the RFL-Series Data Loggers. Global Regulatory Round-up: Anticipated Changes for 2017 First - the MHRA has published new Orange and Green guides, available at Gov.UK And the EMA is implementing new Clinical Trials Regulation. - See more at European Commission Web site. Recently in March, the EMA and the FDA announced they would initiate the new Mutual Reliance Initiative - where both regions will recognize each other's GMP inspections of pharmaceutical manufacturing facilities. The hope is that this cooperation between regulators will reduce duplicated inspections, helping reduce inspection costs, allowing both regulators to allocate more resources to areas underserved by their inspectorates. See more on the FDA's Website Also from the FDA, both the CDER and CBER have published their plans for guidance updates for 2017: CBER and CDER For China, CFDA Offers Technical Guidance on Clinical Trials (24 January 2017) - See more at RAPs.org In Japan, the PMDA is joining an initiative to share information on GMP inspections The Programme to rationalize international GMP inspections of active pharmaceutical ingredients/active substances manufacturers And late breaking news from Health Canada, it was announced that they will allow eCTD-only for Drug Applications by January 2018 - See more at Health Canada's Website As always - don't hesitate to contact us by email!
Contributors Janice Bennett-Livingston Marketing Manager Email [email protected] In addition to editing the Vaisala Life Science blog, Janice Bennett-Livingston is the Global Life Science Marketing Manager for Vaisala's Industrial Measurements business area. Pre-Vaisala writing credits include a monthly column called "Research Watch" for Canada's award-winning magazine alive, as well as articles in Canadian Living and other periodicals. Other past work: copywriting for DDB Canada, technical writing at Business Objects, and communications specialist for the British Columbia Child & Family Research Institute. Paul Daniel, Vaisala Senior GxP Regulatory Compliance Expert Paul Daniel has worked in the GMP-regulated industries for over 25 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems. At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor’s degree in biology. Connect on LinkedIn Jon Aldous Senior Product Manager Jon Aldous was the product manager for Vaisala’s Continuous Monitoring systems. His background includes electronics and electrical science with a Bachelor of Engineering. He taught digital and mechanical engineering at the University of the West of England. He also worked on the development of poly-silicon micro structures used within thermopiles and intelligent data acquisition sensors. After immigrating to the US, he worked for 12 years with Kaye Instruments as the lead product manager developing thermal validation systems. He joined Veriteq Instruments, which was acquired by Vaisala in 2010. During his time at Vaisala Jon’s role has expanded to oversee the research and continuous development of software and hardware for Vaisala’s environmental monitoring systems.
Janice Bennett-Livingston Marketing Manager Email [email protected] In addition to editing the Vaisala Life Science blog, Janice Bennett-Livingston is the Global Life Science Marketing Manager for Vaisala's Industrial Measurements business area. Pre-Vaisala writing credits include a monthly column called "Research Watch" for Canada's award-winning magazine alive, as well as articles in Canadian Living and other periodicals. Other past work: copywriting for DDB Canada, technical writing at Business Objects, and communications specialist for the British Columbia Child & Family Research Institute.
Paul Daniel, Vaisala Senior GxP Regulatory Compliance Expert Paul Daniel has worked in the GMP-regulated industries for over 25 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems. At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor’s degree in biology. Connect on LinkedIn
Jon Aldous Senior Product Manager Jon Aldous was the product manager for Vaisala’s Continuous Monitoring systems. His background includes electronics and electrical science with a Bachelor of Engineering. He taught digital and mechanical engineering at the University of the West of England. He also worked on the development of poly-silicon micro structures used within thermopiles and intelligent data acquisition sensors. After immigrating to the US, he worked for 12 years with Kaye Instruments as the lead product manager developing thermal validation systems. He joined Veriteq Instruments, which was acquired by Vaisala in 2010. During his time at Vaisala Jon’s role has expanded to oversee the research and continuous development of software and hardware for Vaisala’s environmental monitoring systems.
