Data Governance for Computer Systems Regulated by FDA

Duration: 75 Minutes
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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.
Data Governance for FDA
Instructor: Carolyn Troiano
Product ID: 502212
We will also touch on aspects of 21 CFR Part 11, the FDA’s guidance for electronic records and electronic signatures (ER/ES). There are many security aspects related to ER/ES that are key components of a sound validation and data governance program.

Objectives of the Presentation
  • Discuss the best practices necessary to ensure all systems are validated appropriately
  • Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk
  • Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
  • Learn how to develop a strategic approach to data governance to ensure data integrity, quality, identity, accessibility, and security
  • Q&A
Why Should you Attend
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.

Areas Covered
In this webinar, we 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
  • Q&A
Who will Benefit
This webinar will provide valuable assistance to all personnel in:
  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Personnel
  • Supply Chain Personnel
  • Audit Personnel
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
Topic Background
Data is a company’s key asset, and must be collected and managed in a way that is compliant with FDA requirements. The systems housing data must be validated in accordance with FDA guidelines for computer system validation and must be maintained in a validated state in order to support this. A good data governance program will include aspects of computer system validation and maintenance, and also help identify the resources, processes and procedures needed to support the integrity, identity, authenticity, quality, and accessibility of your data. It is far more costly to lose sight of this and risk having data discarded or invalidated by FDA than it is to build a sound data governance program. We will also address 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).
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Recorded Session for one participant
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Live Session - How it works
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  • 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
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  • 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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