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Affiliate Medical Compliance Oversight (Charlie Chen, LQR of Taiwan) -…
Affiliate Medical Compliance Oversight
(Charlie Chen, LQR of Taiwan)
Procedure Document Updates
Local SOPs
CSOD Training
Awareness Sessions
Spot-check
non-GxP SOPs
Global SOPs
Document Alignment
Environmental
Changes
Local Regulations
MDR and IVDR
GVP
GCP
Data Privacy
Processes and Systems
e.g. Metric Changes
e.g. Voyager/OSMD
e.g. DAN and EPS
Global Regulations
Organizational Effectiveness
New or Updated Job Family, Roles
Training Assignment and Removal
Organizational Structures
Personnel and Resources
Audits and Inspections
MAH PV Inspection
GARA (Group Audit & Risk Advisory) Audit
GCP Site Inspection
Process-specific Audit
GCP Sponsor Inspection
Affiliate-specific Audit
Compliance Overview
SIRIUS
MAP Metrics
DiCELA Metrics
SPOT
Oversight Activities
SPOP Yearly Review
% of SPOP in place
Approved SP Log
Quality Events
Self-identified Deviations
From Audit and Inspection
Finding Trend Dashboard
Training
QMS-related
RoVig
Risks and Opportunities
CARISMA or Risk Registry
Medical Compliance
Health Status
Five (5) Areas
Metrics Commentary