Data Governance for Computer Systems Regulated by FDA

Product Id IQW19B0213
Speaker Carolyn Troiano
Level Intermediate
Duration 90 Mins
  • Description
  • Why should you attend
  • Areas covered
  • Who will benefit
  • Speaker

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.

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
  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Analytical Chemists
  • Laboratory Managers
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Clinical Data Managers and Scientists
  • Quality Managers, Chemists and Microbiologists
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.

 

 

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