Imagine this scenario: A mid-size pharmaceutical manufacturer had been operating with what they believed was a “strong enough” quality system. Their last FDA inspection was several
Regulatory inspections today go far beyond verifying that procedures exist. We often see Life Sciences organizations pass internal audits yet face scrutiny during FDA or
Imagine this scenario: A mid-size Pharmaceutical manufacturer had been operating with what they believed was a “strong enough” quality system. Their last FDA inspection was several years ago, and aside
Empowering Teams for Successful FDA Inspections For Pharmaceutical, Biotech, and Medical device companies, FDA inspections are critical events that assess compliance with GxP, cGMP, and regulatory requirements. The ability of
Building a Culture of Continuous Compliance In the highly regulated Pharmaceutical, Biotechnology, and Medical device industries, audit readiness is a vital component of business success. Whether it is an internal audit to assess your own quality systems or
Preparing for an FDA inspection is a critical business moment for life sciences organizations. BioBoston Consulting delivers focused FDA Inspection Readiness services that combine technical