About Us

Committed to speeding innovation for science-driven organizations, from product ideation through commercialization.

Events

BioProduction 2015

Event Date

October 14-15, 2015

Event Location

Citywest Hotel Conference & Event Centre | Dublin | Ireland

Event Overview

The biopharmaceutical industry has made a capital investment of approximately $8 billion in new facilities in Ireland. With most of this coming in the last 10 years, representing close to the biggest wave of investment in new biotech facilities anywhere in the world. Join us in Dublin this year for BioProduction!

Hear Us Present

Justin Neway, Vice President and General Manager, Process Production Operations Senior Fellow, BIOVIA Science Council will speak on the topic “The Made to Cure Industry Solution Experience: Reducing Product Variability in the Biologics Manufacturing Process and Quality Enterprise” on Day 1 at 3:10pm.

Talk Title

The Made to Cure Industry Solution Experience: Reducing Product Variability in the Biologics Manufacturing Process and Quality Enterprise

Abstract

Process and Quality data stored in systems like Paper Records, On-line Data Historians, LIMS, EBR, ERP, etc., is organized differently to serve the needs of each system’s specialized users. This creates problems for those who need to perform data analysis that spans these systems to understand the sources of process variability using initiatives like Quality by Design (QbD) and Process Robustness (PRB). It also presents needless barriers to identifying Critical Process Parameters (CPP’s) and Critical Quality Attributes (CQA’s) for implementation of automated process monitoring with alerts for review-by-exception as part of Continued Process Verification (CPV) initiatives. These users need automated self-service access, aggregation and contextualization of all data types across all process steps, in a validated collaborative environment for analysis and reporting that eliminates labor intensive, error-prone spreadsheet methods. This presentation will describe how biotech and pharmaceutical companies have overcome these problems by using the BIOVIA Made to Cure Industry Solution Experience which provides self-service, on-demand access, aggregation and automated contextualization of data from multiple disparate electronic and paper-based source systems.

Conference Website

Browse By: