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Seminars
Transition from Computer System Validation (CSV) to Computer Software Assurance (CSA)
The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen a trend toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations such as use of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT that have more recently begun to be used more heavily in life science companies.
Webinars
Import Seafood HACCP: Understanding FDA Requirements for U.S. Seafood Importers
Importing seafood into the United States carries specific responsibilities under FDA’s Seafood HACCP regulations. Firms importing fish and fishery products must comply with 21 CFR 123.12 and establish appropriate verification procedures to demonstrate seafood import compliance.
On Demand Webinars
Animal Food GRAS: Unpacking the Essentials
This webinar explores the history and legal basis of GRAS, compares GRAS to alternative regulatory pathways, and reviews FDA notification and self-determined GRAS approaches. The presentation also discusses the role of qualified experts in establishing GRAS conclusions, species-specific safety considerations, and regulatory challenges associated with novel animal food ingredients.