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Downloads, White Papers
Using ISA-88 to Define a Compliant Packaging Environment
This white paper was originally presented by Ron Williams of EnteGreat and Moin Hussain of McNeil Consumer Healthcare at the 2007 World Batch Forum North America Conference in Baltimore, MD, USA on May 2, 2007.
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Paper Overview
This paper describes how a leading Life Science manufacturer, McNeil Consumer Healthcare, has applied the ISA-88 standard to define and sustain a compliant packaging environment. McNeil understood the strength of ISA-88 for batch processing, but was unsure of how ISA-88 could support its FDA-regulated packaging operations. By engaging ISA-88 from the beginning of its new packaging program, McNeil came to realize the potential of ISA-88 to provide much more than just automated control systems definition. Using ISA-88 as the framework for the entire packaging line operations, including change management, documentation, training, regulatory compliance, and configuration control, enabled McNeil to develop a comprehensive operations and governance program for the packaging line which spans all stakeholder functions/disciplines.
Paper Outline
- Background
- Business Drivers
- The Vision
- Why ISA-88 Works for Packaging
- Compliant Packaging
- Regulatory Compliance
- Change Management
- Documentation
- Training
- Goverance
- Summary
About the Author
Ron Williams has over 17 years of experience in manufacturing, including work within the Life Sciences (Pharmaceutical and Biotech), Specialty Chemicals, Pulp and Paper, Power, Oil and Gas, Food, Beverage, CPG, Steel, and Automotive industries. Ron's papers, technical sessions and expertise have helped people throughout the industry gain a better understanding in various areas, including manufacturing systems integration within the Manufacturing IT environment, process excellence improvements utilizing the concepts of lean manufacturing, and flexible batch management improvement utilizing industry standard modeling methodology.
Request a copy of this paper - please click here.
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