Organizations in FDA-regulated industries, from pharmaceuticals, biologics and vaccines to tobacco, animal health and medical devices, depend on compliant computer system data management. Best practices built over three decades already help manage these systems cost-effectively; the focus now is governing the data they hold.
This 60-minute FDA data governance webinar presents governance as a quality control discipline for assessing, using, improving, monitoring, maintaining and protecting organizational information, through agreed decision rights that define who may act on which information, when, how and under what circumstances.
You'll learn what data integrity means for FDA compliance, what enforcement trends show, how to build a governance framework, and how to align governed data with CSV, SDLC methodology and 21 CFR Part 11 electronic records and signatures.
Data integrity problems make up a large share of FDA audit and inspection findings, and the agency is watching closely. If you handle data that FDA may inspect, audit or review, a standardized governance program helps you protect its integrity across its life cycle and avoid negative findings.
The session suits IT, QA/QC, lab, manufacturing, warehouse, CSV, clinical, quality and regulatory staff, business stakeholders and testers, and consultants in life sciences and tobacco.
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.
Data integrity problems make up a large share of FDA audit and inspection findings, and the agency is watching closely. If you handle data that FDA may inspect, audit or review, a standardized governance program helps you protect its integrity across its life cycle and avoid negative findings.
The session suits IT, QA/QC, lab, manufacturing, warehouse, CSV, clinical, quality and regulatory staff, business stakeholders and testers, and consultants in life sciences and tobacco.
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 …
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