Innovation in Laboratory and Production Operations

Session 206
Technology Track

Operating laboratories and production facilities at the highest level of quality and efficiency is a constant objective within the Pharmaceutical industry. The industry constantly strives to improve their product lines and enhance research while balancing the needs to be a good steward to the environment and managing operational costs.

Session Description

Recent advances in laboratory and production operations have been developed to improve both quality and efficiency. This session will cover a wide range of topics from new state-of-the-art weighing technologies, the evaluation of the performance of liquid metrology concentration monitors, and methods to reduce energy usage within the laboratory HVAC system, without adversely impacting air quality.

At the conclusion of this session, participants will be able to:

Identify critical balance properties
Establish appropriate balance testing schemes by applying risk management
Integrate weighing process requirements into the company’s quality management system
Understand the choices for process analytical technologies applicable for the monitor and control of buffer preparation processes
Understand how specific process analytical technologies can be applied to both traditional metallic vessel and disposable single use processing systems
Analyze chemical concentration data in terms of LOD and LOQ values
Understand the opportunities to reduce energy usage by applying VAV exhaust technology
Understand the process that is used to determine minimum acceptable volume flow rates using physical dispersion modeling in an atmospheric boundary layer wind tunnel

Leaders

Speakers

Jeff Campie, USA
Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
Edwin Melendez, Principle Consultant, Parexel, USA
Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
Julian Wilkins, Vice President, PharmaConsult US Inc, USA
Paul Wreglesworth, Independent Consultant, United Kingdom

Who Should Attend

Manufacturing / Operations
Service Providers
Suppliers
Regulators

Communities of Practice Members that will Benefit

Biotechnology
C&Q
Containment
Critical Utilities
Engineering Standards Benchmarking
GAMP^®
Good Control Laboratory Practices
HVAC
Operations Management
PQLI^®
Process/Product Development
Project Management
Sustainable Facilities

More information on ISPE's Communities of Practice