QHub Q&A║Rebecca Fuller on QReview
November 5, 2020
In this post, you’ll hear from our newest Consulting Director, Rebecca Fuller. With more than 30 years of industry experience, we wanted to get her
In this post, you’ll hear from our newest Consulting Director, Rebecca Fuller. With more than 30 years of industry experience, we wanted to get her
QualityHub partnered with a major medical device company to develop and execute regulatory strategies addressing FDA consent decrees and recidivist warning letters, stabilizing and improving
QualityHub led a comprehensive 14-month quality system rebuild and FDA remediation for a medical device implant manufacturer, including audits, compliance master planning, and inspection coaching,
QualityHub partnered with international pharmaceutical and medical device companies to proactively enhance quality systems, including CAPA overhauls, compliance plans, investigation training, and FDA inspection preparation.
A global cardiovascular health leader faced a corporate FDA warning letter due to multiple recalls and quality failures, prompting a comprehensive, multi-year remediation effort led