Management estimated that they would require 15 consultants to work both onsite and remotely on short four–eight week assignments to prepare for the inspection. Within a period of two weeks, we found qualified, available consultants from multiple countries across Europe and arranged for their travel and accommodations.
Our consultants had to quickly familiarize themselves with the product line and adjust to the local working culture immediately. Their main task was to implement FDA compliance standards into all of the company’s quality documentation, technical files, systems, and processes.
Oxford’s FDA expert performed a mock inspection at two sites and led the inspection readiness project. The other 14 consultants then focused on several potential weak points, which included software validation, review of SOPs, CFR 820 compliance, ISO 14971/Risk Management Files, CAPAs, deviations and complaints handling, and Human Factors Engineering.