This weekend I’m snuggling up with Breaking Things at Work by Gavin Miller, and hope to have a review for Sunday, as well as some thoughts on just why the Luddites were right about why folks hate their jobs, and if there are lessons to learn in this new phase we are entering into of virtual and hybrid work.
Here’s a great interview with Gavin Miller from On The Media
The US FDA has released the latest plan to collect quality metrics data in an attempt to unstall efforts to obtain manufacturing quality data as a means of mitigating potential drug shortages and promoting enhanced quality management in the pharmaceutical industry.
The agency promised that this program would be different from the original quality metrics draft guidance unveiled in 2015, as well as the revised draft guidance issued in 2016. The newly devised plan is based in the feedback it received through its voluntary quality metrics site visit and quality metrics feedback programs launched in 2018.
The FDA has identified four areas, and the individual metrics within these areas, for reporting:
Manufacturing process performance: This can include the proportion of lots that were accepted in a given time period as well as the proportion of lots manufactured without a non-conformance
Pharmaceutical quality system (PQS) effectiveness: This metric can include the effectiveness of the corrective action and prevention action (CAPA) which can cover the number of CAPAs initiated or closed on time
Laboratory performance: This can include the proportion of laboratory test that are completed on schedule
Supply chain robustness: This can include the extent to which shipments are delivered on-time and containing the correct quantity
On 2 March, FDA’s Device Good Manufacturing Practice Advisory Committee will meet for the first time since 2013 to discuss the agency’s proposal. The meeting materials, and the meeting itself, could offer the first glimpse at the future of the QSR.
I have it on my calendar, and I don’t currently work with medical devices. That has changed before and can change again. More importantly, this QSR update is an important milestone for those who watch the FDA’s take on quality systems and is worth attending.
In the 14 years since permission-less blockchains were created absolutely no one has come up with a single useful thing to do with the technology. The majority of blockchain activity is just about maintaining the blockchain — not about buying or selling things or actually doing anything that has any value to society.
The massive amounts of energy and ewaste is a requirement, maybe even a feature, to the wasteful endeavor of blockchain. Given how that energy waste is a requirement to ensure ‘security’ (for what it is) there’s really no way to fix the problem. And why bother since the whole thing is a tulip-bubble anyways. It exists for speculation.
Blockchain has not offered one feasible solution, and cannot offer a single one, to issues of data integrity or anti-counterfeiting. It isn’t what the technology is designed to do. All it is designed to do is spend a lot of money to drive a speculative bubble,
I leave you with a comic, which succinctly summarizes how I feel everytime blockchain comes up in a professional context.
McKinsey paid $600 million as a result of its illegal activities around the sales of opioid drugs. Frankly, I’m amazed that the company has not gone the way of Arthur Anderson, a fate that is well deserved.
Yet the company still exists and continues to do creepy stuff, for example, take a look at Cory Doctorow’s article on their kids’ program.
Hiring McKinsey is basically like hiring the Tony Soprano Consulting Company.