Use this three-step process to prevent disasters in implementing decisions
Even if you don’t get certified, you will still gain from a well-implemented management system
While this worldwide, unintended experiment continues we won’t immediately know if we have passed the peak
Five questions to ask and address in sequence
Quality and safety may occupy two different departments, but the reality is that safety is an aspect of quality
Remote consulting, auditing, and training here to stay
Crisis management plans protect companies
Conversation with NIST’s Sheng Lin-Gibson and Vijay Srinivasan
The context of the organization
How to evolve quality management into business management
Improve business processes to reduce waste, increase sustainability, and maximize profits
New process is qualitative rather than quantitative
Computer system, cutting corners, self-certification all play a part
Stop fighting the auditors and get back to basics
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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.
Standards under development seek to make AI practical for more settings
Future systems start with documentation hierarchies but focus on electronic process documentation