Webinar to Highlight Extractables & Leachables
A free webinar is to cover current regulatory guidelines and provide a general approach to designing extractables and leachables studies for evaluating and qualifying finished containers and the process materials used in pharmaceutical production.
On 17 May 2012 a free webinar organised by CPHI Worldwide will cover current regulatory guidelines (FDA - PQRI) and provide a general approach to designing extractables and leachables studies for evaluating and qualifying finished containers and the process materials used in pharmaceutical production.
It will review ICH guidelines, as well as the global pharmacopeial requirements and will look at extractables and leachables data sharing (ELSIE) and relevant genotoxins.
Participants in the webinar will gain understanding of the current regulatory requirements and expectations; learn what needs to be taken into consideration when designing an extractables and leachables study, and gain confidence regarding laboratory testing practices and the securi
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