CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.
Furry critters have no place in a medical device manufacturing facility.
As medical device companies move technology concepts into the commercialization stage, collaborating with outside partners is crucial.
Manufacturers that make custom devices must move beyond conventional engineering practices to an automated and collaborative engineer-to-order process.
In this week’s edition of Devine Guidance , Dr. D will complete (it’s about time!) the review of section 820.70 of the Quality System Regulation (QSR), and focus on subsection (h) manufacturing material, and (i) automated processes.
In this week’s edition of Devine Guidance (DG), Dr. D will continue down the production and process controls path by examining the requirements for subsections (f) buildings, and (g) equipment. Buildings and equipment fall into Dr. D’s not rocket science category.
As promised, in the week’s edition of Devine Guidance (DG) Dr. D will continue with analyzing the requirements associated with 21 CFR, Part 820 – Section 820.70; subsections (c) environmental control, (d) personnel, and (e) contamination control.