A major field of opportunity for the head of quality
Here’s a sample of some of the stories our readers found most interesting in 2019
Complete all 11 quizzes, and you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training
Want to be part of FDA’s SaMD precertification program? Get your QMS up to par.
Producing safe food doesn’t just make sense. It’s the law.
The wine industry shows how eco-friendly production can benefit both companies and consumers
A crucial method for differentiation (and profitability) in a tight market
A tardy response will be costly and painful
Data-driven decisions are only as good as the data that drive them
How manufacturers can best prepare as the FDA moves to adopt ISO 13485:2016
The agency seeks to balance expedient exemptions against public transparency about medical devices
European MDR update: Lowest risk medical devices must comply by May 26, 2020
Three-quarters of life sciences CIOs and IT execs say security risks are main reason for opposing cloud technologies
Setting up for long-term success
Questions linger about FDA processes that seem to favor medical device companies
Confronting the fear of being displaced by machines
The velocity at which digital transformation is reshaping business models seems utterly chaotic in a compliance-based industry
Huge amounts of biometric, DNA, and diagnostic data enable personalized medicine. They also enable unscrupulous and discriminatory marketing.
A cloud-based QMS can help address common international standards and regulations
Particularly in regulated industries, you really do want to know what goes into the sausage