Dr. David Vincent, Chief Scientific Officer at VTI Life Sciences discusses with Cesar Lucero, VTI’s Validation and Automation Manager current trends in implementing artificial intelligence within the life science industry.
Discover expert-led GxP training conferences focused on vital topics in life sciences compliance, quality assurance, and regulatory standards. Enhance your skills with practical knowledge shared by industry leaders and stay updated on the latest best practices. Explore the full calendar of upcoming GxP training events. Go HERE for more info and to sign up. Use … Read more
The FDA’s CSA guidance formally replaces legacy validation models with a risk-based approach tied to intended use and patient safety impact. This paper covers the key framework elements, practical implementation considerations, and areas where additional FDA guidance is still needed. Key topics include: risk classification at the feature level, flexible testing strategies, leveraging supplier evidence, … Read more
Dive into the world of Computer System Validation (CSV) and Computer Software Assurance (CSA) at CSV & CSA University 2025! This two-day event is tailored for professionals focused on quality assurance, compliance, and the integration of technology within regulated industries. Gain a comprehensive understanding of the latest methodologies and regulatory expectations that govern software validation … Read more
Author: Dr. David Vincent, B.Sc., MPH, Ph.D., Epidemiologist & Public Health Strategist Introduction Pandemics are no longer rare, once-in-a-generation catastrophes, they are a recurring global threat shaped by a confluence of biological, environmental, and geopolitical forces. From the devastating toll of the COVID-19 pandemic to the quiet but dangerous resurgence of zoonotic diseases and antimicrobial … Read more
By Dr. David Vincent, VTI Life Sciences CSO/ B.Sc., MPH, PhD Introduction Each year, snakebite envenoming remains a substantial yet underrecognized global public health problem, disproportionately affecting rural and resource-constrained populations, particularly in sub-Saharan Africa, South Asia, Southeast Asia, and parts of Latin America. The burden is heaviest among agricultural workers, children, and communities with … Read more
Dr. David W. Vincent, Ph.D., Chief Scientific Officer (CSO), VTI Life Sciences, Inc. / September 2025 Introduction The US Food and Drug Administration (FDA)’s role in ensuring the safety, efficacy, and quality of medical products is pivotal in safeguarding public health. However, companies in the pharmaceutical, biotechnology, and medical device sectors sometimes find themselves in … Read more
ATTEND VIRTUALLY OR IN PERSON October 9-10 | San Diego San Diego Marriot La Jolla 4240 La Jolla Village Drive, La Jolla, CA 92037 REGISTER NOW DOWNLOAD AGENDA LEARN MORE AI in QMS Session Highlights: Use GenAI Responsibly in Validation and Technical Documentation AI-Powered Risk Management & Intelligent QMS Insights AI in QMS: Otsuka’s Strategy … Read more
Enhancing Compliance, Data Integrity, and Operational Efficiency Introduction The pharmaceutical industry is undergoing a significant transformation driven by digitization and artificial intelligence (AI). As regulatory expectations from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to emphasize data integrity, traceability, and compliance, Good Manufacturing Practice (GMP) … Read more
