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Tag Archives: Quality System Regulations
Statistical Techniques
This week’s Devine Guidance on 21 CFR, Part 820 – Subpart O (Statistical Techniques) is the proverbial “Final Act” in regards to the QSR. There is a plethora of data, standards, and websites that can provide useful information needed to create robust procedure(s) for establishing effective statistical control and sampling plans. Establishing robust statistical procedures will mitigate the potential receipt of a Form 483.
For an Effective Supplier Selection Process
To my colleagues who have decided to rejoin me for an ongoing exploration into the trials and tribulations of effective supplier management for the medical device industry, thank you for returning. I hope you will be able to glean some useful information from the compilation of current industry practices, concepts extracted from my doctoral dissertation, and an overall common-sense approach to supplier quality. It is my personal belief that pursing the ideas presented within this paper, and scheduled to…
Manage Your Suppliers
The medical device industry is in a perpetual state of change as technology continues to evolve, while standards and regulations are in constant state of rescript to ensure the ongoing safety and efficacy of medical devices. This dynamic industry demands an equally dynamic approach to quality. Antediluvian approaches to quality that were premised on inspection, inspection, and more inspection, are just not viable options today. In the coming months, I would like to enlist my colleagues and ask that you …
