Fundamentals of Pharmaceutical Inspection & Evidence Collection Techniques

Outline

• Introduction to inspection types and objectives

• Regulatory requirements for pharmaceutical inspection

• Inspection phases: pre-inspection, on-site, and post-inspection

• Evidence collection techniques (Physical – Documentation – Interview)

• Evidence validation and analytical tools

• Reporting inspection findings & observation classification

• Follow-up processes and corrective actions (CAPA)

• Handling conflicts and communication skills

• Common inspection pitfalls and best practices

• Readiness for regulatory authority inspection

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