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Corporate Programs
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 – Corporate Program
Curriculum
4 Sections
16 Lessons
2 Days
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Phase 1: Diagnostic & Assessment
4
1.1
Review of past FDA audits (483s, Warning Letters, EIRs)
1.2
SOP compliance gap analysis
1.3
Risk mapping across QA, QC, Manufacturing, RA functions
1.4
Stakeholder interviews & readiness surveys
Phase 2: Leadership & Functional Training
4
2.1
Executive briefing: Compliance as a business risk factor
2.2
QA/QC team workshop: Batch records, deviations, OOS/OOT handling
2.3
RA team workshop: Submissions, SMF, Dossier readiness
2.4
Manufacturing team workshop: Shop-floor practices, cleanliness, data entries
Phase 3: Tailored Mock Audit & Simulation
4
3.1
Plant/site-specific mock inspection with walkthrough
3.2
Functional role-based drill (QA → docs, RA → interviews, Manufacturing → floor checks)
3.3
Consolidation of observations & feedback
3.4
Corrective Action & Preventive Action workshop
Phase 4: Audit Playbook & Governance
4
4.1
Development of company-specific Audit Playbook (policies, SOPs, escalation flow)
4.2
CAPA & 483 response templates customized for the client
4.3
Internal governance & monitoring structures
4.4
Sustaining audit readiness culture post-training
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