Content by Dirk Dusharme @ Quality Digest
Taking a Risk-Based Approach to Drug InspectionsA concise history of FDA’s risk-based Site Selection Model
Tue, 02/19/2019 - 12:01
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests. The goal…
Inside Quality Digest Live for Jan. 25, 2019In this episode: China trade and a demo of web-based management system software
Wed, 01/30/2019 - 08:03
We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of the current U.S.-China trade war. Does China really care, and where do U.S. multinationals go from here? Also…
Inside Quality Digest Live for January 11, 2019From smart toilets to smart people... we cover it all
Tue, 01/15/2019 - 12:00
Who’s more clever, engineers or designers? Alexa-connected toilet, anyone? How do you promote rigorous thinking? We discussed all of that and more during this week’s QDL. “CES brings you... the Alexa-connected toilet!’ Just when you thought that…
Inside Quality Digest Live for December 21, 2018Being small, thinking big, catching on fire. We're sure they're connected.
Thu, 01/03/2019 - 12:02
We tied up last year in a neat little bow, talking about how stories define ourselves and our work; waste is waste, no matter your political leanings; and putting numbers from the news in context. “The Gift of Being Small” This article by Quality…
Inside Quality Digest Live for Dec. 7, 2018From bioethics to the death of Le Grand K
Wed, 12/12/2018 - 12:00
In this episode we look at bioethics, next-gen manufacturing employees, and the death of Le Grand K. What happens if customers want designer babies? We discuss the latest news about a Chinese researcher who claims to have edited the genes of two…
Inside Quality Digest Live for Nov. 16, 2018ISO vs. FDA audits, Baldrige winners, and what we can learn from GE
Wed, 11/28/2018 - 12:02
In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients. “GE’s Lessons Won’t Determine Whether You Succeed or Fail” Does the success or failure of GE’s CEO…
Canada's MDSAP Mandate Could Be Bad for Canadian HealthcareBy scaring off small medical-device companies, Canada could limit number of important and innovative products
Wed, 11/14/2018 - 12:01
The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be…
Inside Quality Digest Live for Oct. 26, 2018What kind of review would you give the Bates Motel?
Wed, 10/31/2018 - 11:59
In this episode we look at a history of quality, how you serve your customer in the housing industry, and what makes a good review. “Young couples ‘trapped in car dependency’” Building entry-level housing along highways may give couples the chance…
Inside Quality Digest Live for Oct. 12, 2018All about data—and genomes
Thu, 10/18/2018 - 12:02
In this episode we look at data, data, more data, and then... engineering the perfect human? “Your Data Are Your Most Valuable Assets” Just what the heck is Quality 4.0? Remember this acronym: CIA. No, not that CIA. Nicole Radziwill explains. “…
Coordinate Metrology Society Helps Companies Grow an Apprenticeship ProgramIndustry is trying to create its own skilled workforce
Thu, 10/04/2018 - 12:02
During the past five to 10 years, the United States has seen more industry and academic institutions embrace apprenticeship programs. According to the Bureau of Labor Statistics, from 2013 to 2017, the number of those participating in apprenticeship…