A New Expert Led Blog Series for JVT Fans


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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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This webinar discusses the basic principles of a quality agreement, as well as the responsibilites, best practices, and FDA suggestions. Download the presentation here.

This webinar will discuss the fundamentals of effective and US Food and Drug Administration-compliant process validation. The background to FDA's Process Validation: General Principles and Practices will be discussed, and the requirements will be analyzed.

At IVT's Validation Week EU, Cliff Campbell explained the nature of identifying variables in the process validation lifecycle. As Campbell explained and demonstrated, providing visual representations of data and processes can be extremely helpful when pinpointing the different variables that continually appear in validation processes.

The Winter and Spring Issues of the Journal of GXP Compliance featured papers on technical/quality agreements, devoloping test cases, academic GLP and GCLP programs, change control, and validating the SaaS application. The following questions are adapted from papers published in the Journal of GXP Compliance and are designed to test your knowledge of the best practices for global compliance.

Attempts allowed:Unlimited
Pass rate:75 %
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At IVT's Validation Week EU, Dawn Tavalsky described the various global regulations that recommend variation control. Analyzing requirements for pharmaceuticals and medical devices, Tavalsky highlighted variation control from the GHTF Medical Device Process Validation Guidance, the Code of Federal Regulations, and the US Food and Drug Administration's Process Validation Guidance.

While most professionals know there are three stages of the process validation lifecycle, many are unaware of the activities dictated by each stage. As part of IVT's pre-Validation Week webinar, Paul Pluta, Ph.D., explained the prescribed endeavors of Stage 1, Stage 2, and Stage 3 of process validation as recommended by the US Food and Drug Administration.