Data Governance for Computer Systems Regulated by FDA

Instructor: Carolyn Troiano
Product ID: 704745
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This webinar will assist those responsible for establishing, managing or supporting a data governance program within your organization where FDA compliance must be met. There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing attendees to the most critical and cost-effective of methods, techniques and tools available. Attendees will have a better grasp of how to leverage the best practices across all systems by creating a standardized program for data governance.

Why Should You Attend:

This webcast will discuss the importance of establishing a data governance framework and program for data that is collected, analyzed, stored or reported using a computer system subject to FDA regulations. A data governance framework is a logical structure for classifying, organizing and communicating complex activities involved in making decisions about and taking action on enterprise data. As data governed by FDA must adhere 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, this course will look at ways to leverage these in developing an overall data governance framework and program.

After attending this course, attendees 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, when, under what circumstances, and, finally, using what methods.

Areas Covered in the Webinar:

  • Linking 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
  • Designing data governance processes that encompass people, processes and technology
  • Understand the policies and procedures necessary to support the data governance framework

Who Will Benefit:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, quality control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

  • Data Owners
  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Compliance and Audit Managers
  • Laboratory Managers
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Instructor Profile:

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Ms. Troiano worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

She has participated in industry conferences and is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s educational fund as a project management instructor for non-profit organizations.

Topic Background:

Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a step further, we are now looking at ways to ensure the data that resides on these systems is also managed in a compliant manner, and one that will provide the best results for operations at the lowest cost.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
21 CFR Part 11 Compliance for SaaS/Cloud Applications - 80202SEM

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