Data Governance for FDA-Regulated Computer Systems

Duration: 60 Minutes
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.
Data Governance
Instructor: Carolyn Troiano
Product ID: 500843

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
Why Should you Attend:
You should attend this webinar if you are responsible for establishing, managing or supporting a data governance program within your organization where FDA compliance must be met.

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.

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 the attendees to the most critical and cost-effective of methods, techniques and tools available.

Objectives of the Presentation:
We 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, we will look at ways to leverage these in developing an overall data governance framework and program.

Who can Benefit:
Information technology analysts, QC/QA managers and analysts, clinical data managers and scientists, analytical chemists, compliance managers, lab managers, 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. This webinar will also benefit any consultants working in the pharmaceutical, biologics, vaccine, animal health, medical device, tobacco or other FDA-regulated industry who are involved in computer system implementation, validation, data governance and compliance.

$249
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
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