Pharma Audit Management Foundation Course

Description

Pharma Audit Management Foundation Course

This course provides a structured foundation in pharmaceutical audit management, focusing on planning, conducting, and responding to audits in compliance with global regulatory standards. It equips professionals with the knowledge and practical skills needed to manage internal, supplier, and regulatory audits effectively while ensuring quality system compliance, data integrity, and continuous improvement.

Key Learning Areas

• Introduction to Pharma Audits & Regulatory Expectations
  Understanding the purpose, types, and scope of audits including internal, external, supplier, and regulatory inspections.
• Audit Planning & Preparation
  Developing audit plans, checklists, risk-based audit approaches, and defining audit scope, criteria, and objectives.
• Conducting Effective Audits
  Techniques for interviewing, document review, evidence collection, and identifying non-conformities during audits.
• Audit Reporting & Documentation
  Preparing clear, objective audit reports with proper classification of findings, evidence documentation, and communication of outcomes.
• CAPA (Corrective and Preventive Actions)
  Root cause analysis, developing CAPA plans, tracking effectiveness, and ensuring timely closure of audit observations.
• Regulatory Compliance & Inspection Readiness
  Aligning audit practices with GMP, GLP, GDP, and regulatory expectations to maintain continuous inspection readiness.
• Supplier & Vendor Audits
  Evaluating third-party manufacturers, service providers, and suppliers for compliance and quality assurance.
• Audit Lifecycle & Continuous Improvement
  Monitoring audit trends, improving quality systems, and implementing lessons learned for sustained compliance.