On-Site or Virtual Drug or Biologic GMP Audit / Mock FDA Inspection / Compliance Gap Assessment Led by DeVaughn Edwards – Former FDA Investigator | Pharma Executive | Owner of FD-AID, LLC

🔍 What’s Included in the Base Service:

• One full day of on-site or virtual GMP audit, mock FDA inspection, or gap assessment
• Pre-engagement planning call (30–60 minutes)
• Customized checklist and inspection plan specific to your operations
• Real-time observations and compliance coaching
• End-of-day verbal debrief
• Direct email: devaughn@fdaid.org, fdaidllc@gmail.com, devaughn@gmail.com

🖥️ Virtual Audits (Alternative to On-Site Audits):

For clients preferring a remote option, virtual GMP audits are available at a flat rate of $1,500/day. These audits include:

• Pre-audit planning call
• Remote review of SOPs, batch records, validation data, CAPAs, etc.
• Live virtual facility walkthrough (via Zoom, Teams, or your preferred platform)
• End-of-day verbal debrief
• Optional written report for an additional $850

Virtual audits are ideal for early-stage firms, follow-ups, or budget-conscious clients needing compliance support without travel.

✅ Deliverables Summary:

| Deliverable | Included in Base | Optional |

|-------------------------|------------------|------------------|

| On-Site Audit (1-day) | ✅ Yes | |

| Verbal Debrief | ✅ Yes | |

| Written Audit Report | ❌ No | ✅ Yes ($850) |

| Pre-Audit Planning Call | ✅ Yes | |

| Virtual Audit | ❌ No | ✅ Yes ($1,500) |

| Virtual Follow-Up | ❌ No | ✅ Yes ($250) |

📅 Booking Process:

1. After purchase, you will be contacted within 24 hours to:
   • Finalize audit objectives
   • Confirm location and audit dates
   • Provide a travel estimate (if applicable)
2. Once travel is paid, services are scheduled, and any pre-engagement forms or NDAs can be signed.

🔁 Cancellation Policy:

• Refunds allowed up to 14 days prior to scheduled audit (minus Gumroad processing fees)
• One complimentary rescheduling permitted if made at least 7 days in advance
• No refunds for travel once booked unless refundable fares are used

🌍 International Engagements:

• All countries are in scope except those subject to current U.S. travel bans or OFAC sanctions.
• For all international audits, a separate invoice will be sent following the planning call. This invoice will require:
  • 50% of estimated travel and lodging costs paid in advance
  • The remaining 50% will be invoiced upon completion, based on actual costs
• Travel estimates include airfare (business class if flight exceeds 6 hours), lodging, ground transportation, visa/documentation fees, and any applicable international taxes
• Note: Locations requiring a visa or government clearance may require extended lead time to schedule

🧳 U.S. Domestic Travel & Expenses:

• Travel from Tampa, FL to U.S. client sites will be billed at actual cost (airfare, hotel, transport).
• Expenses will be estimated and invoiced following the planning call and must be paid prior to booking.

📅 Booking Process:

1. Purchase the service option best suited to your needs (on-site or virtual).
2. Within 24 hours, you will be contacted to schedule a planning call to:
   • Confirm location and audit dates
   • Define your service scope (mock FDA inspection, gap assessment, etc.)
   • Review any NDA requirements
   • For international audits, a travel invoice will be issued after this call
3. Once payment is received for travel (if applicable), your audit dates will be confirmed.