Inspection Readiness

PharmQS offers guidance on developing an SME training plan, including selecting the best personnel to participate, assessing vulnerabilities and strengths, understanding common FDA interrogation techniques, and testing readiness with simulated inspection interviews.

FDA investigators are knocking at your door—are you ready? Your first thoughts may be of logistics, meeting space, document availability, the condition of your facility but what about personnel? Are your employees prepared to face FDA investigators who are trained thoroughly to investigate a manufacturer’s operations?

Training for SMEs—in fact, any personnel involved in inspections should go beyond the obvious topics of company policies, protocols, SOPs, and federal regulations. Trainees should learn about inspection etiquette, presentation skills; the techniques investigators will use to elicit information, the types of questions they may ask and how to respond effectively.