CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, is excited to announce that Chief Scientific Officer Brandon Zurawlow will lead the CCI training course at the Industrial Production Processes (IPP) Ltd Container Closure Integrity Testing Seminar on March 10, 2022 at IPP headquarters in Bromsgrove, England.
“Opportunities to engage with industry, gain insights, and simultaneously share my own knowledge and experience regarding the challenges and intricacies of USP 1207 CCI testing are always worthwhile,” commented Brandon Zurawlow. “These types of programs provide the ideal platform to directly engage with companies facing integrity-related regulatory challenges across all types of container and package systems.”
Brandon’s primary goal is to impart attendees with a robust understanding of the USP 1207 Method Selection process. CCI method selection is dependent multiple variables, including product formulation, package system design and materials, specific study goals or leaks of concern, as well as the lifecycle stage at which testing is to be performed. By the end of the seminar, attendees will understand the following:
Applications and limitations of key USP 1207 leak test technologies.
That not all CCI technologies are suitable for every use-case.
How the lifecycle approach is implemented to reduce risk and increase knowledge of the product-package system (package integrity profile).
The lifecycle stages at which CCI may be considered or evaluated, including package development, manufacturing and assembly validation, distribution, and stability.
That multiple technologies may be used based upon the specific products, packages, and lifecycle stages to be considered (the toolbox approach).
Brandon has spent more than a decade working in the niche field of medical product container and package system qualification, with unique focus on USP 1207 integrity testing. As the Chief Scientific Officer for CS Analytical, he works with clients daily helping them define and implement comprehensive container qualification strategies that meet ever-evolving and increasing regulatory requirements. He is often viewed as one of the world’s few experts in this unique space.
To learn more about the seminar, register to attend or make travel arrangements, please contact Steven Gruar, UK Manager, Life Sciences, IPP by email: sgruar@ippgroupltd.com.
About CS Analytical Laboratory
The world’s only cGMP, FDA-registered contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, the CS Analytical Team includes world-leading experts and thought-leaders on FDA and EU regulatory expectations and USP and EP primary package testing requirements inclusive of container closure integrity (CCI) testing (CCIT). Test services include CCI method development, validation, and analysis, USP/EP/JP physical and physicochemical testing, and Comprehensive and Complementary services for all common or unique primary packaging components and systems inclusive of glass, plastic, elastomeric, and more. CS Analytical is the single source to ensure a regulated industry product-package system meets strict, complex, and ever-changing regulatory requirements.
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