FDA Inspections - Preparation, Support, and Follow Up for FDA Inspections

Regulatory Foundations for FDA Inspections

• Overview of key regulations forming the basis of the FDA Compliance Program
• Understanding the QMSR (21 CFR Part 820) and how it replaces the former QSR
• Requirements under 21 CFR Part 803 (Medical Device Reporting)
• Requirements under 21 CFR Part 806 (Corrections & Removals)
• How the updated FDA Compliance Program Manual defines the scope and conduct of inspections

Organization and Prioritization of Foreign Inspections

• How the FDA selects and prioritizes foreign manufacturers
• Inspection triggers and risk based criteria
• New CPM driven, patient risk centric prioritization logic

Preparing for an FDA Inspection

• Pre inspection readiness activities
• Conducting internal mock inspections
• Ensuring documentation, processes, and personnel are inspection ready
• Preparing QMSR aligned process evidence (design and development, production, CAPA, UDI, complaint handling)
• Ensuring linkage to U.S. specific regulatory requirements per QMSR 820.10 ("applicable regulatory requirements")

Conduct During an FDA Inspection

• Appropriate behavior and communication with investigators
• Understanding FDA’s inspection approach (QSIT, Compliance Manuals)
• Managing document requests and interviews
• Avoiding common pitfalls
• Awareness that under QMSR, inspectors may review:
  • Internal audit reports
  • Supplier audit reports
  • Management review outputs (Explicitly allowed under QMSR; legacy 820.180(c) no longer applies)
• Understanding how the CPM supports the new ISO aligned inspection program (Program 7382.850)

Handling Deviations and Post Inspection Activities

• Understanding FDA findings and deviations
• Deadlines, consequences, sanctions
• Strategies for responding to Form 483
• Preparing and submitting corrective actions
• Integrating QMSR aligned CAPA and management responsibility requirements into remediation

This course is ideal for professionals who need clear, actionable understanding of FDA inspections. It equips participants to prepare thoroughly, conduct mock inspections, and manage interactions with FDA investigators confidently.

Why You Should Attend

The training reflects the major regulatory transformation to QMSR and the new CPM based, patient risk centric inspection model, helping organizations prepare for increased transparency requirements and the FDA’s ability to review internal audit results, supplier audits, and management review documentation.