The Webinar will be held on Tuesday, October 3rd from 4:00pm to 5:00pm EST. The key topic will focus on the increasing complexity of current regulatory expectations in the qualification process for drug delivery devices. Mechanical testing will be highlighted, which is performed to evaluate the device’s performance, inclusive of container closure integrity, dose verification, and functionality tests such as break loose and glide. Attendees can expect to leave the webinar with an understanding of:
- General regulatory requirements and industry best practices in container / device development and qualification.
- The role of functional and mechanical tests in product design, validation, and commercialization of such systems.
- Differing requirements stemming from the increased complexity of drug delivery systems, such as vials, prefilled syringes, and automated drug delivery systems.
- A review of relevant standards and guidance documents specific to mechanical testing, including USP 382 and 1207, ISO 11607 and 11608, and an array of ASTM standards, as well as the interconnections between them.
- Strategies to reduce risk by incorporating relevant studies throughout the full lifecycle of a product-package system.
This educational webinar is free of charge to attend. To register as a formal attendee, please click here.
About CS Analytical Laboratory
The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world’s leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP 1207 services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.
About Instron
Instron is a leading global manufacturer of testing equipment for the material and structural testing markets used to evaluate materials ranging from native tissue to advanced high-strength alloys. Instron systems perform a variety of tests such as compression, cyclic, fatigue, impact, multi-axis, rheology, tensile, and torsion. Instron is a wholly owned subsidiary of Illinois Tool Works Inc. For more information, visit http://www.instron.com.
Media Contact
Brian Mulhall, CS Analytical, 1-888-571-1207, [email protected], https://csanalytical.com/
SOURCE CS Analytical
