In this webinar, we answer all your questions about qualifying and validating GxP Environments.
Known as the “High Prophet of Quality”, Edwards Deming said: “In God we trust; all others bring data.”
Validation, qualification, verification activities are all about bringing data, proving that every component or process in your system will do what it’s designed or implemented to do, as desired, as expected, every time.
In pharmaceutical, biotech, and medical device industries, validation activities confirm that a system or process consistently achieves its objective. Validation safeguards the final product, the intended supply chain, and public health.
Global regulations, standards and guidance are freely available and read by almost anyone involved in quality control and assurance in life science industries. But regulations and standards are essentially ideals and objectives. They don’t tell you how to solve real world challenges, they don’t provide “how to” directions, and they can’t account for technological advances coming at an increasing rate.
This is why we receive so many questions on Validation, Qualification, Verification, and Computer Systems Assurance. In this webinar, Vaisala’s Senior Regulatory Expert Paul Daniel is joined by Axis Consulting principal Josh Keenan. Together, they will answer your questions on how to bring the data in GxP-regulated environments. See post-webinar Q&A blog.
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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.
Josh Keenan has worked in the pharmaceutical industry for over 25 years, with a focus on Quality Management Systems (QMS) and special expertise in qualification and validation. In 2010 Josh founded Axis Consulting to offer a combination of hands-on services and management consulting. Axis Consulting supports pharmaceutical, biotechnology, and medical device companies with Research & Development, Systems Engineering, Quality Assurance, Regulatory Affairs, and Validation/Qualification.
As the principal of Axis Consulting, Josh supports clients with Quality Systems remediation efforts and GMP validation and engineering projects throughout the US, Canada, China, and Mexico. Josh holds a Bachelor of Science in Biochemistry from Western Washington University. He received his Master's in Transportation and Logistics from American Military University.