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 …
Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Introduction to Generative AI for Accountants
Dealing With Difficult People In Life & Work
Surviving and Thriving Organizational Change and Loss: The …
Impact Assessment and Risk Management for Change Control
How to Write Effective Audit Observations: The Principles f…
Excel Deep Dive: Advanced Tips & Techniques – A 3-hour Work…
FDA Regulation of Artificial Intelligence/ Machine Learning
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Marijuana: Compliance and Safety in the Workplace
Stressed Out: How to Handle Conflict, Difficult People and …
2025 Top Employment Regulations That Will Impact Employers!
How to Handle Workplace Conversations Around Politics and R…
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud,…
How to Give Corrective Feedback: The CARE Model - Eliminati…
Improving Employee Engagement & Retention Through Stay Inte…
SOPs - How to Write Them to Satisfy those Inspectors
Why EBITDA Doesn't Spell Cash Flow and What Does
Marketing to Medicare or Medicaid Beneficiaries - What You …
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Human Error Reduction Techniques for Floor Supervisors
Documenting Misconduct that Will Stand Up in Court
Tattoos, hijabs, piercings, and pink hair: The challenges …
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Project Management for Non-Project Managers - How to commun…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Sunshine Act Reporting - Clarification for Clinical Research
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Female to Female Hostility @Workplace: All you Need to Know
Humane Layoffs: How to Let People Go with Compassion and De…
Onboarding is NOT Orientation - How to Improve the New Empl…
Managing Toxic & Other Employees Who Have Attitude Issues
Building GMP Excellence: A Guide to Implementing Compliant …
Excel Power Skills: Master Functions, Formulas, and Macros …