Data Governance for Computer Systems Regulated by FDA
Carolyn Troiano is Keynote Speaker at ComplianceKey.She has more than 30 years of experience during which she worked directly, or as a consultant, for many top-tier pharmaceutical, medical device and biological companies in the US and Europe. She was responsible for computer system validation compliance activities across all GxP functions at a major pharmaceutical company. She developed computer system validation programs and strategies and was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. Carolyn has participated in industry conf........
Overview
Effective and compliant computer system data management is critical to organisations in the pharmaceutical, biologic, 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.
Why should you attend this webinar?
After attending this course, you will understand data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and protecting organisational information. It is a system of decision rights and account abilities 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.
Areas Covered in the Session:
This webinar will cover the following key areas:
- Establishing a data governance framework and program for data that is collected, analysed, stored or reported using a computer system subject to FDA regulations
- How to use a data governance framework as a logical structure for classifying, organising 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
- Q&A
Who can Benefit:
Within FDA-regulated companies, people in the following roles will benefit from this presentation:
- Computer System Validation Specialists
- Information Technology Professionals
- Data Analysts and Managers
- Automation Analysts and Managers
- QC/QA Analysts and Managers
- Laboratory Analysts and Managers
- Manufacturing Analysts and Supervisors
- Supply Chain Managers and Analysts
- Compliance and Audit Managers
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors of Computer Systems
- System Implementation, Integration and Validation Specialists
