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.
Interested in doing business of health products in Canada? This free webinar provides an overview of the Canadian regulation on natural health products and how EAS can assist companies with the diverse requirements of Health Canada.
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology
