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
Ice-breaker: “Your worst audit moment”
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