Whether you believe synthetic data to be real or fake, the overall market for it is expected to grow from $351.2 million in 2023 to $2,339.8 million by 2030 (Synthetic Data Generation Market Forecast | Fortune Business Insights). This statistic can make the most hardened cynic’s ears perk up. But, surely, in our world of regulated medicinal […]
Lachman Consultants has continued its active engagement with efforts to combat the global drug supply chain shortages. Despite the FDA’s significant success in helping to prevent 236 drug shortages in 2023, the problem persists and may be about to get worse. The current problem, external environment, and emerging risks are highlighted in a recent publication […]
Day 2 of the 2024 PDA/FDA Joint Regulatory Conference kicked off in a similar format to Day 1 with a panel discussion, moderated by Andrew Hopkins, that delivered key messages from various FDA leaders. An explanation of the imminent changes in the Agency’s organizational structure (CBER, CDER, and CVM) dominated the conversation. However, an impactful response from […]
U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight. Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]
A couple of months ago, when we returned from Barcelona to San Francisco, it was impossible to check in online for some reason. Then the news broke about flight disruptions due to the CrowdStrike software update! Some flights, including ours, were only a couple of hours delayed. However, many more passengers were affected even further […]
Did you ever REALLY wonder what is being done by our federal government and other stakeholders to combat the current drug shortage situation? This past June 12th, representatives from various government agencies as well as industry leaders and the Duke-Margolis ReVAMP Drug Supply Chain Consortium (with yours truly participating on the expert panel) met to […]
When new technology takes the industry by storm, does your QA team have the “education, training, and experience” necessary to execute their required responsibilities? Even when outsourced, the contract giver needs to have the requisite skills to provide adequate oversight. These concepts are also summarized in the FDA publication “Q10 Pharmaceutical Quality System” regarding both […]
The current state of drug shortages in the supply chain is under continued pressure, both outside of and within the U.S. According to the FDA, there are currently 105 products in shortage in the U.S. (here) as of the drafting of this blog. Not only are the shortages continuing, but adherence to section 506C of the […]
Forget the cadence of the traditional three-to-five-year business plan when it comes to Artificial Intelligence (AI). The pace of change in this environment has indicators that need to be followed on a quarter-by-quarter basis. In Q1, we wrote about the fast evolving environment both from the legal perspective and the regulatory aspect in blogs that […]
Do you struggle with modern data backup methods on industrial automation? Sometimes these “islands of automation” are not conducive to well-established methods when there is no apparent network connection. In cases such as these, a frequent choice is to use a flash drive. This technology is available in most Human Machine Interfaces (HMIs) and Programmable […]
