Since the FDA’s dietary supplement cGMP regulations (21 CFR Part 111) were published, specifications and testing have been consistently one of the most frequently cited FDA observations. Specifically, industry continues to face challenges in complying with the specification and testing requirements for dietary supplement components.
Simply put, Artificial Intelligence (AI) is the ability of a computer to perform tasks commonly associated with humans. In the area of food safety and food regulatory compliance, there are many tasks in which AI applications can be used, some more advanced than others.
Foreign entities who operate in US FDA-regulated industries must have an appointed FDA US agent before they can import products into the US. At a minimum these FDA US agents provide the most basic of required services. However, agents with relevant experience and knowledge can provide much more.
This two-hour training will be a scientific dive into the regulatory requirement of claims substantiation. Several topics including the following will be discussed along with real case examples: which types of evidence are available and where to find them; what are high quality and low quality evidence; when is the evidence irrelevant to the claim being made; and how to write claims that can be substantiated.
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology
