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 …
Controller Challenges in Changing Times: New Roles as Strat…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Stress, Change And Team Resilience Through Humor: An Intera…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
How to Prepare For and Host a FDA Inspection and Respond to…
Sunshine Act Reporting - Clarification for Clinical Research
The Importance of the first 5 seconds when presenting
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Complaint Handling and Management: From Receipt to Trending
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Managing Toxic Employees: Strategies For Leaders To Effecti…
ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT
Understanding Artificial Intelligence (AI) and the Incredib…
6-Hour Virtual Boot Camp on Microsoft Power BI
Onboarding is NOT Orientation - How to Improve the New Empl…
The Monte Carlo Simulations in Excel for Risky Investments
ChatGPT and Project Management: Leveraging AI for Project M…
Project Management for administrative professionals
Workplace Investigations 101: How to Conduct your Investiga…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Construction Lending And Real Credit Administration: Evalua…
Dealing With Difficult People: At Work & In Life
Understanding Accounting for non - Accounting professionals
New Form 1099 Reporting Requirements: 2025 Compliance Update
Human Error Reduction Techniques for Floor Supervisors
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
7 Ways To Beat Burnout: Without Quitting Your Job
Treating Employees Like Adults: Discipline versus Empowerme…
Understanding EBITDA – Definition, Formula & Calculation
Ethical Terminations: Navigating Employee Exits with Legal …
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
How to Write Procedures to Avoid Human Errors
FDA Proposes Framework to Advance Credibility of AI Models
Project Management for Non-Project Managers - Scheduling yo…
Validation Statistics for Non-Statisticians
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
4-Hour Virtual Seminar on Hidden Secrets of Selling & Marke…
The Alphabet Soup: When the FMLA, ADA, COBRA, and Workers' …
Talent Management: How to Leverage AI and ChatGPT Tools for…
Offboarding with Care: Conducting Legal & Ethical Employee …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…