Nov 20, 2025 | Drugs, Medical Devices, Seminar, Tobacco
The life science industries, including pharmaceutical, medical device, biotechnology, biological, tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA.
We have seen the recent trend in industry toward using cloud-based services, Software-as-a-Service (SaaS) solutions, and other technical innovations. More recently, we have begun to see newer, emerging technologies including Artificial Intelligence (AI), Machine Learning (ML) algorithms & Large Language Models (LLMs), such as ChatGPT begin to find a presence within these companies.
While life science companies tend to lag behind other markets in using these technologies, they are catching up and we are seeing much greater use of AI in the development, testing, release & management of life science products with quality and compliance. This is most predominant in the medical device industry, where we find both medical devices that include software as a product component & Software-as-a-Medical-Device (SaMD) products that function as a medical device without the need for any hardware.
Nov 20, 2025 | On Demand Webinar
Now that the FDA has issued your firm a 483 or Warning Letter, what to do next? This webinar will cover the expectations and requirements of the FDA for responding to inspectional findings, best practices, and tips for creating a comprehensive response, including corrective and preventive actions taken and planned to address the observations.
Nov 11, 2025 | On Demand Webinar
Be prepared when (not if) the FDA is at your doorstep for an inspection! This webinar will cover the processes and procedures to have in place to handle any regulatory inspections at your facility, and the set ups, best practices, and tips for personnel throughout the inspection process, ensuring that the inspection goes as smoothly as possible.
Sep 30, 2025 | Foods, On Demand Webinar
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business. These disruptions lead to lost time, spoiled shipments, and unhappy customers. But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
Sep 24, 2025 | Foods, On Demand Webinar
A Guide to FSMA 204: Sorting Through the Confusion of the FDA’s New Traceability Rule for Added Food Safety Presented by Tim Lombardo and Thomas Bell The final Food Safety Modernization Act rule, the Food Traceability Rule – commonly referred to as FSMA 204 – will...
