PDA Metro Chapter: Inspection Readiness

As global regulatory expectations for Good Manufacturing Practice (GMP) continue to evolve, inspection readiness is increasingly viewed as an ongoing state rather than a periodic activity. For organizations involved in the development, manufacture, testing, and oversight of pharmaceutical and biopharmaceutical products, sustained readiness is essential to ensuring product quality, patient safety, and regulatory confidence.

This presentation will outline a lifecycle-based approach to GMP inspection readiness that integrates quality systems, risk management, and organizational culture. Key topics include proactive data integrity governance, inspection-focused risk assessment, and the alignment of operational activities with effective quality management practices. The discussion emphasizes cross-functional collaboration across development, manufacturing, quality control, quality assurance, and regulatory affairs to support consistent execution and clear accountability.

Attendees will gain high-level, practical insights into inspection-ready documentation, personnel preparedness, effective inspection conduct, and the use of inspection outcomes to drive continuous improvement. By positioning inspection readiness as a strategic capability rather than a reactive response, this session offers a broadly applicable perspective across product modalities, lifecycle stages, and global regulatory environments.