About Us

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

Events

Visit us at the BioProcess International European Summit

Conference Website

Event Date

12-13 April, 2016

Event Location

Vienna, Austria

Hear Us Present

Tuesday, 12 April @ 12.35 - 13.05

Dr. Justin Neway, Vice President and Managing Director, Process Production Operations will be presenting 'The Impact of Recent Regulatory Trends on the Pharmaceutical Manufacturing Process and Quality Enterprise’.

Abstract

On-going industry consolidation and the growth of contract manufacturing in recent years, coupled with an increasing focus on quality and risk by regulatory agencies, has highlighted the need to promote data-driven collaboration across the manufacturing process and quality enterprise, including outsourced operations (CMO’s).  A recent industry survey highlighted the problems of multiple disparate quality systems and data sources, along with the lack of an effective quality culture and the lack of quality metrics, as the top challenges for shortening time to market.  These represent needless barriers to improved process understanding and control of variability, because they impede the implementation of role-based process monitoring with automated alerts for review-by-exception to improve process performance and compliance with Continued Process Verification (CPV), and Manufacturing Quality Metrics (MQM) initiatives.  They can be removed by eliminating labor intensive, error-prone spreadsheet methods and instead providing end users with easy access to all process and quality data in disparate sources in a readily usable form that takes process genealogy into account.  This presentation will describe how leading life science companies have accomplished this by using a validated environment for self-service, on-demand access to process and quality data, integrated with collaborative capabilities for report creation, editing, tracking, auditing, archiving and retrieval.

We look forward to seeing you in Vienna!

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