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.
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 …
Understanding and Analyzing Financial Statements
Onboarding is Not Orientation: How to Improve Your New Hire…
Managing Toxic & Other Employees Who have Attitude Issues
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Excel & ChatGPT Synergy Masterclass: Unleashing Financial A…
Introduction to Microsoft Power BI Dashboards
Drive Recruiting Success with the Using Recruiting Metrics …
2025 EEOC & Employers: Investigating Claims of Harassment …
Impact Assessments For Supplier Change Notices
Mastering Job Descriptions: Legal and Practical Insights fo…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
What is in Store for Employers When Updating Employee Handb…
Designing Employee Experiences to Build a Culture of Compli…
Onboarding Best Practices for 2025: Proven Strategies to Po…
Accounting For Non Accountants : Debit, Credits And Financi…
Creating a Successful Job Rotation Program
The Anti-Kickback Statute: Enforcement and Recent Updates
FDA Compliance And Laboratory Computer System Validation
How To Create Psychological Safety in your Organization
Aligning Your HR Strategy with Your Business Strategy
Transforming Anger And Conflict Into Collaborative Problem …
How to Give Corrective Feedback: The CARE Model - Eliminati…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Zero Acceptance Sampling to Reduce Inspection Costs
Identifying, Managing, and Retaining High Potential Employe…
AI at Your Service: Enhancing Your Microsoft OfficeSkills w…
Why EBITDA Doesn't Spell Cash Flow and What Does
FDA Recommendations for Artificial Intelligence/Machine Lea…
Project Management for Non-Project Managers - How to commun…
Dealing With Difficult People In Life & Work
Developing and Implementing Quality Culture in the Organiza…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Enhancing Pivot Tables with Images: Visualize Your Data Lik…
How to Write Effective Audit Observations: The Principles f…
How to Write Contracts for Procurement Professionals
Uplifting the Credibility of HR: How to Build the Credibili…
Strategic Interviewing & Selection: Getting the Right Talen…
Performance of Root Cause Analysis, CAPA, and Effectiveness…
FDA Audit Best Practices - Do's and Don'ts
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …