"Walk me through this investigation." You didn't write it. The author left the company last year. The inspector is waiting.
That's one of the most stressful moments in any inspection: defending work done before you arrived, or by a colleague who's out of the office. The quality issue may be small. How you communicate about it decides whether one question stays one question, or becomes ten.
PQS Course A: Inspection Readiness for Individual Contributors & SMEs is a 2-day, hands-on live simulation built for the people who actually face inspectors.
You'll work through a simulated audit using mock documents modeled on recent FDA 483 observations, and practice:
• Defending someone else's work clearly and credibly
• Answering inspector questions concisely, without oversharing
• Leading document walkthroughs that stay on track
• Shifting from anxiety to a challenge mindset when the pressure rises
What makes this different: the training is built on stress exposure and stress inoculation training (SET/SIT), the same research-backed approach used to prepare military personnel, first responders, and athletes for high-pressure moments. You'll learn practical strategies, then try them in live simulations until they feel natural. The goal is to shift how you see the audit, from a threat to dread into a challenge you're ready for, so you walk into the room prepared and able to contribute.
📅 October 14-15 | Four Points by Sheraton, Norwood, MA | 9:00 AM to 5:00 PM
💲 $1,400 founding cohort rate (the February session is $2,800)
👥 Only 12 seats, so everyone gets live practice time
🔗 Register at https://lnkd.in/gKe7a5hJ
Founding Participant Scholarship: I'm also offering one fully funded (free) seat, with priority for professionals currently between roles in biotech, pharma, or regulatory.
To be considered, comment below by October 6 and share what you find most challenging about inspections or regulatory interactions, or what interests you most about this program.
Preparing for an upcoming inspection, or know someone who is? Please share this post, or message me about bringing your team.
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