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, when, under what circumstances, and, finally, using what methods.
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:
Upon completion of this session, attendees will have an understanding of how to:
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:
Upon completion of this session, attendees will have an understanding of how to:
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.
Carolyn Troiano
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 …
Managing Toxic Employees: Strategies For Leaders To Effecti…
DOL Reverses Course on Independent Contractor Rule for 2026…
The emergence of Social Determinants of Healthcare
Leadership: Strategic Planning and Decision Making
Beginners Guide to Data Transformations in Power Query
Understanding EBITDA – Definition, Formula & Calculation
Navigating HR Like A Pro: What Every Small Business & New H…
HPLC Analytical Method Development and Validation
ChatGPT and Project Management: Leveraging AI for Project M…
Managing Projects When AI Joins the Team: Human Judgment, A…
Negotiating Skills For Professional Results - Winning Strat…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Paying and Receiving Payments for Referrals: You Can Go to …
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
Tattoos, hijabs, piercings, and pink hair: The challenges …
The Importance of the first 5 seconds when presenting
Ten Red Flags that Signal Financial Distress in Business Cu…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
The New W4 - How to Assist Employees with Proper Completion…
Transforming Anger And Conflict Into Collaborative Problem …
Microsoft Excel PivotTables: Basics of Data Analysis for Bu…
4-Hour Virtual Seminar on Management Skills For New Managers
Fatal Errors Employers Make When Updating Employee Handbook…
Tools for New Managers: Connecting with Employees to Optimi…
Supervisor Excellence: Skills to Lead High-Performing Teams
The Manager’s Playbook for Leading After Layoffs: Quickly R…
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
Launch Your Career: The Ultimate Guide for Emerging Profess…
Mastering Performance Management: Strategies for Continuous…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Pivot tables beginner to advanced + 20 advanced Pivot table…
AI Fundamentals for All Leaders and Managers: How to Work S…
Rewiring Your Emotional Triggers: Leading with Clarity and …
The $1M Mistake: EEOC Discrimination Claims Employers Make …
Using Claude in Excel for Productivity, Automation & Data A…
AI in B2B Marketing: What Your Compliance Team Needs to Know