The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to...

21 CFR Part 11 stands for Part 11 of Title 21 of the Code of Federal Regulations. The US FDA issued this final Part 11 regulation in March 1997, which became effective in August 1997. It governs the FDA regulations for electronic signatures and elect...

Understanding current Good Manufacturing Practices (cGMP) in the pharmaceutical industry can be challenging. That’s why Quality professionals in the pharma industry actively seek to understand the details of cGMP regulations. In most cases, they also...

Quality control (QC) processes can be a significant bottleneck in the smooth functioning of a pharmaceutical manufacturing unit if a lot of material gets stacked into either incoming raw material or the quarantined area before it gets approved. The c...

To successfully get a drug FDA approved, the data on the drug’s effects need to be reviewed by the Center for Drug Evaluation and Research (CDER), which in turn needs to determine that the drug’s benefits notably outweigh its known and potential risk...

For thousands of years, our ancestors have used the cannabis plant to treat illnesses. The medicinal use of the cannabis flower is made possible thanks to its hundreds of chemical compounds that create pleasant sensations, feelings of relief, and hea...

The new year is here, making it the perfect time to gear up for conferences and events that will keep you updated on the latest developments in the Pharma and Biotech world. In this blog post, we’ll look at some of the events and conferences you may ...