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2019 - Specification and OOS for Pharma, Biopharma and Combination Products
Date2019-08-28
Deadline2019-08-28
VenueOnline Event, USA - United States 
KeywordsSpecifications; CPP; Quality Attribute
Topics/Call fo Papers
Overview of following in preparation of understanding setting specifications:
CQA and Quality Attribute
CPP and Control limits
OOS, OOT and OOE
Specifications, Release vs Shelf-Life Specifications
Specification settings based on Early-Stage Development or preclinical data
Specification settings based on preclinical and clinical data
Lifecycle approach to setting global specifications
Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities
CQA and Quality Attribute
CPP and Control limits
OOS, OOT and OOE
Specifications, Release vs Shelf-Life Specifications
Specification settings based on Early-Stage Development or preclinical data
Specification settings based on preclinical and clinical data
Lifecycle approach to setting global specifications
Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities
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Last modified: 2019-08-15 02:26:21