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.
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.
WHY SHOULD YOU ATTEND?
Anyone involved with activities related to data that is subject to inspection, audit, or review by, FDA should attend the webinar to learn how to do so in a way that ensures the integrity of the data is maintained throughout its entire life cycle. Currently, FDA trends in compliance and enforcement indicate a high percentage of data integrity issues in their typical audit and inspection findings. This is a key area that the FDA is focused on, and should be of interest to those who want to avoid negative findings during such an audit or inspection of their regulated activities. 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.
AREA COVERED
This webinar will cover the following key areas:
- Define the meaning of data integrity and focusing on the criteria necessary for FDA compliance
- Provide an overview of recent FDA compliance and enforcement trends that focus on data integrity issues identified during audit and inspection
- 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 is captured and stored with integrity, and is maintained as such throughout its entire life cycle?
- Q&A
LEARNING OBJECTIVES
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
WHO WILL BENEFIT?
- Information Technology analysts
- Information Technology developers and testers
- QC/QA managers and analysts
- Analytical chemists
- Laboratory managers
- Automation analysts
- Manufacturing supervisors and other key personnel
- Warehouse and supply chain supervisors and other key personnel
- Computer System Validation (CSV) 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
Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of products must understand and conform to FDA requirements for data quality and integrity. Finally, anyone who is developing and maintaining software used in these industries should be aware of the requirements for data integrity for their systems.
Anyone involved with activities related to data that is subject to inspection, audit, or review by, FDA should attend the webinar to learn how to do so in a way that ensures the integrity of the data is maintained throughout its entire life cycle. Currently, FDA trends in compliance and enforcement indicate a high percentage of data integrity issues in their typical audit and inspection findings. This is a key area that the FDA is focused on, and should be of interest to those who want to avoid negative findings during such an audit or inspection of their regulated activities. 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.
This webinar will cover the following key areas:
- Define the meaning of data integrity and focusing on the criteria necessary for FDA compliance
- Provide an overview of recent FDA compliance and enforcement trends that focus on data integrity issues identified during audit and inspection
- 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 is captured and stored with integrity, and is maintained as such throughout its entire life cycle?
- Q&A
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
- Information Technology analysts
- Information Technology developers and testers
- QC/QA managers and analysts
- Analytical chemists
- Laboratory managers
- Automation analysts
- Manufacturing supervisors and other key personnel
- Warehouse and supply chain supervisors and other key personnel
- Computer System Validation (CSV) 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
Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of products must understand and conform to FDA requirements for data quality and integrity. Finally, anyone who is developing and maintaining software used in these industries should be aware of the requirements for data integrity for their systems.
Speaker Profile

Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device 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. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and 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 …
Upcoming Webinars

Interactive dashboards & analytics in Excel

Copilot and HR: An Introduction for HR Professionals

4-Hour Virtual Seminar on Bootcamp on Excel

Leading Across Generations: 5 Challenges & 10 Strategies to…


I-9 Audits: Strengthening Your Immigration Compliance Strat…

Fair Lending in 2025: New Regulations, Examinations and Enf…


Tattoos, hijabs, piercings, and pink hair: The challenges …

Using Emotional Intelligence to Elevate Your Leadership

ChatGPT & HR: How HR Recruiting Professionals Can Leverage …

FDA Trends in Compliance and Enforcement in Computer System…

Elevate Your Workplace Wellness: 10 Critical Wellness Facto…

How to Manage the Legal Landmine of the FMLA, ADA and Worke…

How to Write a Successful Job Hazard Analysis


How to Write Right for Better Business Communication

How to Prepare For and Host a FDA Inspection and Respond to…

Public Speaking: Overcoming The Fear of Public Speaking

From Good to Great: The Secrets to an Optimized LinkedIn Pr…



Workplace Investigations 101: How to Conduct your Investiga…

Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…

The Five Cs Of Commercial Credit: The Basic Elements Of Cre…

Transforming Anger And Conflict Into Collaborative Problem …


Navigating Alcohol and Drug Addiction Protections Under the…


Reduce Stress in the Workplace: Effective Ways to Handle Co…



Transforming HR with AI: Unlocking Excellence and Innovation

Creating Employee Handbooks that Protect You and Support th…

FDA Technology Modernization Action Plan (TMAP) and Impact …


Transform Data into Insights: A Beginners Guide to Excel Pi…


Mindful Communication:The Key to Meaningful Conversations i…

FDA Proposes Framework to Advance Credibility of AI Models

50+ new Excel features so far this decade

FMLA Compliance in 2025: A Comprehensive Guide & Strategies…

Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…

Managing Toxic Employees: Strategies For Leaders To Effecti…

Hiring and Retaining Employees in this Crazy Economy

Harassment, Bullying, Gossip, Confrontational and Disruptiv…