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Bespoke Courses
Family Succession
Executive Succession
Investor Value Creation
Value Added Services
Managed LMS
Instructional Design
Training Calendar
Showcase
Events
Contact Us
Contact Us
Corporate Programs
Bespoke Courses
Family Succession
Executive Succession
Investor Value Creation
Value Added Services
Managed LMS
Instructional Design
Training Calendar
Showcase
Events
Contact Us
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US-FDA Audit Preparedness – Deep Dive Workshop
Curriculum
5 Sections
20 Lessons
1 Day
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FDA Inspection Lifecycle
4
1.1
Stages of inspection (Preparation → Execution → Closure)
1.2
Types of FDA inspections (Pre-approval, Routine, For-Cause, Follow-up)
1.3
Investigator roles & audit psychology
1.4
Recent trends in FDA inspection focus
Data Integrity & Documentation
4
2.1
ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate)
2.2
Record-keeping & electronic data integrity (Part 11 compliance)
2.3
Common documentation pitfalls that lead to 483s
2.4
Good Documentation Practices (GDP) vs Poor Documentation Practices (PDP)
Handling Investigator Questions
4
3.1
How to respond concisely & factually
3.2
Managing stress & body language during audits
3.3
Role-specific communication (QA, Manufacturing, RA)
3.4
Escalation protocols & when to involve leadership
Mock Audit Simulation
4
4.1
Walkthrough of an audit scenario (shop floor, QA docs, RA desk)
4.2
Recording observations as auditors do
4.3
Live debrief with feedback on responses
4.4
Identifying immediate gaps and improvements
Corrective Action Planning
4
5.1
How to structure a CAPA plan (Root Cause, Action, Effectiveness)
5.2
Responding to Form 483 observations effectively
5.3
Preventive measures & internal audit alignment
5.4
Building an audit-ready culture
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