Design failure mode and effects analysis (DFMEA) and a look at better masks to prevent spread of Covid-19
How an audit is conducted has changed significantly. Why audits are conducted is exactly the same.
When failure is not an option
Software tool aids cost, liability analysis for ergonomics issues
Adaptation in the face of adversity
Purified steam maintains product integrity while filter cleaning and sterilization prolongs equipment life
Mounting evidence indicates the agency’s Coronavirus Treatment Acceleration Program may be inadequate
Government agencies and consumers fall prey to knockoffs and unapproved vendors
PPE counterfeits endanger lives. Testing ensures real PPE does its job.
Use this three-step process to prevent disasters in implementing decisions
Making information accessible, understandable, and actionable is essential for optimizing every level of your organization
While this worldwide, unintended experiment continues we won’t immediately know if we have passed the peak
Quality and safety may occupy two different departments, but the reality is that safety is an aspect of quality
Not everything that can be counted counts
Conversation with NIST’s Sheng Lin-Gibson and Vijay Srinivasan
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.