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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
Global Regulations
MDR and IVDR
GVP
GCP
Data Privacy
Legal Manufacturer
Processes and Systems
e.g. Metric Changes
e.g. Voyager/OSMD/PCS
e.g. DAN and FPS
Local Regulations
Organizational Effectiveness
Adequacy of Resources
Roles and Responsibilities
New or Updated Training Roles
Role Mappings
JD Management
Organizational Structures
Audits and Inspections
MAH PV Inspection
Multisite Audit (GCP)
GCP Site Inspection
Process Audit
GCP Sponsor Inspection
Affiliate Audit
GARA (Group Audit & Risk Advisory) 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
Assignment and Removal
Risks and Opportunities
CARISMA or Risk Registry
Medical Compliance
Health Status
Five (5) Areas
Metrics Commentary
Personnel Qualification
CV
Learner Identification and Training Assignment