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SOP 3 describes how organizational roles and training are defined, assigned, and maintained to ensure competence and compliance within your company’s Quality Management System.


It outlines management responsibilities, QA oversight, and staff qualification principles according to GxP and ICH Q10 standards.

This SOP is pre-filled (approximately 98% complete), requiring only company-specific details such as department names and QA reviewer signature.

 

Includes:

  • Organizational hierarchy and quality responsibilities

  • Training program structure and frequency

  • Training documentation and recordkeeping requirements

  • Competence evaluation and re-training triggers

  • Reference to supporting documents (SOP 3.1–3.4)

 

SOP 3 Organization and Training

SKU: SOP-SINGLE-3
€985.00Price
Excluding VAT
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