This blog post was written following a ReedTech webinar (dated 11.7.2019) which focused on helping companies understand how to navigate the state of Cannabidiol (CBD) regulatory environment. This post is for informative purposes only and to provide guidance to minimize risks when labeling, promoting and selling cannabis-derived products in the US. To date, FDA has approved only one CBD drug
21 CFR Part 11 – Electronic Records Part 11 of the Code of Federal Regulations applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions in regards to electronic record keeping. [1] It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software
On July 31, 2019 I had the opportunity to listen into a PricewaterhouseCoopers (PwC) webinar hosted by SDRAN discussing how to build a risk strategy utilizing emerging technologies such as Artificial Intelligence, Blockchain and IOT to improve quality, strengthen compliance and controls such as adverse event controls, reporting and reduce non-conformances. As technology has advanced, the amount of data being
