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.
Biomedical Market Manager
Chief Scientific Officer
This webinar aims to demystify the changing requirements related to the design, validation, and commercialization of drug delivery devices. By explaining the foundational regulatory standards and guidance documents, as well as highlighting the shared requirements between them, attendees will be able to better develop a successful program. More specifically, we will focus on the role of mechanical testing throughout the various stages of product development.Throughout the session, we will discuss the increasing complexity of testing requirements as it relates to the form factor of the device – highlighting additional capabilities needed to evaluate automated drug delivery devices compared to more traditional containers. By the end of the webinar, attendees will have a more wholistic understanding of the functional test requirements for a wide range of devices and be better equipped to navigate the regulatory pathways bringing a product to market.