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Live Webinar Data Governance and Computer Systems Regulated by FDA
Link to Website
After attending this course, you will understand data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and protecting organizational information. It is a system of decision rights and accountabilities for information-related processes, executed according to agreed-upon models which describe who can take what actions with what information, and when, under what circumstances, and, finally, using what methods.
FDA is hitting companies hard on the issue of data integrity, and this course will help you understand the best ways to be compliant.
Why should you attend
Upon completion of this session, attendees will have an understanding of how to:
• Tie data governance activities and investments to corporate drivers, strategies and compliance
• Establish data governance program objectives, decision-making organizational structures and assigned roles and responsibilities that fit within the organizational culture
• Understand the role of data owners vs. data stewards
• Understand the criticality of data identity, trust, security, integrity, accessibility, reliability and consistency
• Design data governance processes that encompass people, processes and technology
• Understand the policies and procedures necessary to support the data governance framework
The attendees will have a good grasp of how to leverage the best practices across all systems by creating a standardized program for data governance. With data integrity one of the leading issues with FDA compliance, this course will help you on the road to success.
This webinar will cover the following key areas:
• Establishing a data governance framework and program for data that is collected, analyzed, stored or reported using a computer system subject to FDA regulations
• How to use a data governance framework as a logical structure for classifying, organizing and communicating complex activities involved in making decisions about and taking action on enterprise data
• How to ensure that data governed by FDA adheres to the principles of Computer System Validation (CSV), System Development Life Cycle (SDLC) Methodology, and Electronic Records and Signatures (21 CFR Part 11), as applicable
• How to leverage industry best practices in developing an overall data governance framework and program
• How to ensure your data integrity is maintained
Who will benefit
Professionals in the following industries may also benefit from the content:
• Medical Device
• Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
• Information technology managers and analysts
• QC/QA managers and analysts
• Clinical data managers and scientists
• Compliance managers
• Lab managers and staff
• Automation analysts
• Computer system validation specialists
• GMP training specialists
• Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
• Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance
• Anyone involved in the planning, execution, and reporting of a clinical trial (sponsor, director, researcher, regulatory role, etc.)
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries.
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