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Technical knowledge

Audit Management
Basic requirements for a Quality System Audit Program, its execution and evidence of compliance to regulatory requirements.
CIAPR CEU: 2TEC for PE & 2GEN for PS

CAPA & Effective Investigations
Inputs to CAPA, requirements for an effective system, robust investigations, & evidence to demonstrate compliance.
CIAPR CEU: 2TEC for PE & 2GEN for PS

Document Controls & Technical Writing
Basic requirements for Documentation Controls in the Quality Management System and best practices for successful SOP's technical writing.
CIAPR CEU: 2TEC for PE & 2GEN for PS

Supplier Management
Fundamental requirements for Supplier selection processes, Supplier performance reviews, audits and records.
CIAPR CEU: 2TEC for PE & 2GEN for PS

Data Integrity
Basic information to begin evaluating and challenging current systems to implement engineering systems and controls that guarantee the regulatory information is accurate and reliable.
CIAPR CEU: 3TEC for PE & 3GEN for PS
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