A smooth FDA inspection can still collapse at the closeout meeting, QualityHub’s Dan McMinn warns. Issues thought resolved days earlier can resurface as findings, especially
QualityHub experts say the opening minutes of an FDA inspection can set the tone for everything that follows. Consultants Dan McMinn and Anne Albertz outline
QualityHub welcomes Melinda Novatny as Senior Principal Consultant, bringing nearly a quarter century of regulatory affairs and quality leadership from Philips Healthcare and Integra LifeSciences.
Part 2 of 2: This Insights piece rounds out the inspection response team, focusing on the scribe, the facility escort, and SMEs, and makes the
Part 1 of 2: This Insights piece makes the case that FDA inspection readiness starts with deliberately structuring a small, well-rehearsed “front-room” team – typically
Who you put in the “front room” can make or break an FDA inspection. QualityHub’s Anne Albertz explains why the best host isn’t your top
Implementing a risk-based CAPA approach requires more than adopting a new decision tree, as demonstrated by QualityHub Senior Consultant Aryssa Wernle’s experience implementing MDIC’s “Make
This QualityHub Expert Brief examines how clear, SOPs strengthen quality systems by standardizing processes, supporting employee competence, and providing objective evidence that work is performed
Mock audits should do more than verify compliance. QualityHub experts say manufacturers should use realistic, risk-based practice inspections that mirror the FDA’s investigative approach, prepare
During a July 22 Town Hall webinar, FDA officials said their new human factors guidance applies only to marketing submissions and doesn’t change MedTech manufacturers’