Final Revised Version of BioPhorum Extractable Testing Recommendation Part 1

Presented by

Frances Sexton, Carsten Worsøe, Ken Wong, and Satish Kumar Mohanvelu

About this talk

Since the first publication of Biophorum (previously known as BPOG) Extractable Testing Recommendation in 2014, the combined team of end-users and suppliers has collaborated to examine all improvement opportunities to the original extractable testing recommendation since 2017. During this webinar, the presenters will highlight all the changes to the final revised version of Biophorum Extractable Testing Recommendation. Specifically, the output of a data review of 26 extractable data sets spanning wide varieties of single use components, which has led to the changes to be made in the original recommendation, will be presented. The revised extractable testing recommendation will be presented to highlight: 1 End-users and suppliers collaboration set up; 2 Specific updates to the extraction study recommendation; 3 Specific areas of flexibility when implementing the protocol; 4 Updates to the analytical test method system suitability; To facilitate a harmonized extractable data reporting to end users, the presenters will introduce the newly designed Biophorum Extractable Data Summary (BEDS) template. Some levels of details with regards to what specific information or format of templates are compulsory and what are flexible for supplier to tailor to their own preferences will be detailed during the webinar. How end users can gain access to these extractable summary reports from suppliers, including subsuppliers, will be addressed. Additionally, several FAQs questions will be presented to clarify some common questions. The webinars will end with 30 minutes of a panel discussion for participants to seek clarify of all presented information.

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