A New Expert Led Blog Series for JVT Fans
Aug 22, 2019 7:00 am EDT
INTRODUCTION:
Applying Data Governance to Manufacturing Systems and Process Automation
As seen at our Data Integrity Validation conference in 2018, Steven Brown of Celgene provides a comprehensive understanding of data governance in manufacturing systems and process automation. This presentation is broken down into 5 easy-to-understand parts:
I. Manufacturing Technology Overview
- Understand technology layers and system architecture
- Define the major features of process automation and manufacturing systems
II. Components of Data Governance
- Regulations, guidelines and the QMS
- Technology controls
- Organizational culture
III. Assess Legacy Systems
- Organize the effort
- Develop assessment boundaries
- Establish an assessment methodology
- Execution, gap identification and remediation
- Information management
- Incorporation into routine operations
IV. Assess Legacy Systems
Learn about the challenges faced by teams and hear about the sort of systems they work with. Teams select an example system and develop a brief sketch of the system architecture to share with the rest of the class. Then, they create a high process map to illustrate how the system is used within the business process. Watch how this group translates this information to a data map to show the data lifecycle and perform a cursory data integrity assessment. Finally, groups identify schemes of remediating gaps, managing assessment information and incorporating system governance requirements into routine operations.
V. Building Data Integrity Into Systems
- Perform early lifecycle assessments
- Validation practices
- System management practices
About Our Speaker
Steven Brown, BSE, MBA, CSSBB, Senior Manager, Systems and Technology Management
Celgene Corporation
Steven Brown is a pharmaceutical professional with 20 years of experience in process engineering, validation, and technical management. His education includes a BS in Chemical Engineering, an MBA, and graduate work in statistics and data analytics. He began his career in the industry as a process engineer in API manufacturing, served for several years as a quality engineer in semiconductor manufacturing, and in 2004 returned to work in the pharmaceutical arena where he managed plant scale up projects, facility renovations, and process validation.
In 2008 he transitioned to apply his skills to manage equipment and computer systems validation in parenteral manufacturing. In the past few years Steven returned to his engineering roots as a technical manager, where he leads a team of highly skilled professionals for design, build, delivery and support of manufacturing and laboratory systems. He is a Six Sigma Black Belt and is working words certifications in program management and software quality assurance. He lives in Phoenix, Arizona, and is passionate in his work to better the lives of patients.
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| Questions: | 6 |
| Attempts allowed: | Unlimited |
| Available: | Always |
| Pass rate: | 75 % |
| Backwards navigation: | Forbidden |
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