This learning module maps out each corner and everything in between when it comes to validation mapping studies. The Food and Drug Administration's (FDA) regulations tell us that we must identify the environmental conditions that can affect the strength, identity, safety, quality, and purity of our regulated products, whether they are pharmaceuticals, medical devices, or biological products. Get the job done right the first time with the following materials.
This webinar will provide 5 simple rules for mapping studies to effectively determine sensor placement. Senior Regulatory Expert, Paul Daniel, will review the regulations and industry guidance on mapping along with discussing a validation method to reduce the total number of sensors required while maintaining your study’s defensibility under audit.
This webinar will include a Question & Answer period to elaborate on the topics.
Whether you are an end user of a hired mapping contractor rest assured this application note will demystify the 5 most frequently asked questions regarding Validation/Mapping
Get your questions answered today.
Good manufacturing practice regulators have sharpened their focus on warehouse storage and distribution practices. Driving this trend is a shift in regulatory thinking, from quality-by-test to quality-by-design systems with an emphasis on level of risk to product quality and patient safety. This step-by-step guide describes how to map a warehouse to comply with internationally recognized GMPs .
Have you ever wondered about leaving mapping sensors in place and using this high-density sensor deployment for monitoring?
This webinar is for you, we analyze the actual costs of continuous mapping, as compared to intermittent mapping studies. The results might surprise you, but the data quality and increase in environmental control is thought provoking.
In this application note we outline how to perform mapping studies for room or chamber validation using viewLinc software with Vaisala data loggers.
Discover more about viewLinc software and its ability to network several types of data loggers or Modbus devices while ensuring data integrity with a secure audit trail, access controls, encryption and authorization levels that fulfill regulatory requirements.
Study what products are the best fit for your project. Our robust Data Loggers and Transmitters are founded on over 85 years of bringing high-quality measurement instruments to the world's most challenging projects.
Video: viewLinc Overview
viewLinc delivers. In this brief overview understand why the Vaisala continuous monitoring system is ideal for both light and heavy industrial environments, as well as GxP-regulated applications.
Dive into the latest and greatest from viewLinc. Explore Vaisala's most recent webinars, whitepapers and product developments that will keep you at the forefront of your next GxP regulated environment conversation.
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