Program Overview
This high-impact, simulation-driven program equips participants with strategic communication techniques to navigate external audits confidently—especially in regulated environments like USFDA, GMP, and WHO audits. Led by a senior audit expert, the course explores the psychology of auditors, critical do’s and don’ts in communication, and how posture, tone, and words can influence audit outcomes. Through role-plays, real case analyses, and hands-on SOP building, attendees sharpen their verbal clarity, body language control, and calmness under pressure. The program culminates in live simulations and feedback, enabling immediate application of learning in real-world audit settings.
Features
- Communicate with auditors using strategic, audit-safe language and clarity.
- Demonstrate confident body language under audit pressure.
- Read auditor cues and adapt in real time during audit interactions.
- Apply audit-specific SOPs and communication protocols in real scenarios.
Target audiences
- Mid- to senior-level professionals across Quality Assurance, Regulatory Affairs, Manufacturing, R&D, Engineering, and Compliance who regularly interact with external auditors.
Curriculum
- 6 Sections
- 29 Lessons
- 1 Day
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- Introduction2
- Strategic Communication in External Audits7
- 2.1What makes audit communication strategic?
- 2.2Types of audits: USFDA, GMP, WHO, Technical (equipment, documentation, process)
- 2.3The auditor mindset: What they look for beyond documents
- 2.4Verbal communication mastery: Clarity, precision, brevity; Acknowledging without over-disclosing; Language to use / avoid (Examples: “I think…” vs. “Let me verify and get back to you.”)
- 2.5Sample SOP: “Communicating with External Auditors – Do’s and Don’ts”
- 2.6Case Study 1: USFDA 483 Observation due to poor verbal interaction – What went wrong?
- 2.7Activity: Communication Diagnosis – Analyze transcript of a poorly handled audit interaction
- Non-Verbal & Postural Mastery in Audits6
- 3.1First impressions: posture, grooming, eye contact
- 3.2Tone, pitch, and pace of voice under pressure
- 3.3Micro-expressions and what they signal to auditors
- 3.4Reading auditor body language
- 3.5Handling difficult questions with calm posture
- 3.6Practice: “Audit Body Language Lab” – Participants role-play audit situations with coaching
- Confidence Building Techniques5
- Audit Room Role-Plays3
- SOPs & Guidelines for Facing External Audits6
- 6.1SOP Walkthrough: “Audit Communication Protocol – USFDA/GMP Focus”
- 6.2SOP: Handling Difficult Audit Queries & Data Integrity Questions
- 6.3Escalation protocol during audit surprises
- 6.4Communication tree during audits (who says what, when, and how)
- 6.5Documentation and post-audit communication protocols
- 6.6Group Activity: Drafting a site-specific communication guideline using SOP template