Data Governance for Computer Systems Regulated by FDA

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Listen By Carolyn Troiano industry reviewer for 21 CFR Part 11, the FDA’s (ER/ES) regulation. along with computer system validation and risk management/compliance at a number of Fortune 100 firms"

Identify the resources, processes and procedures

Description

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).

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.

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

•          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
       •        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

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 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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