
Tracey Sinjen
Principal Consultant

Tracey Sinjen is an experienced Pharmaceutical Consultant with a solid background in the Quality Systems including Visual Inspection. Tracey has experience working with the FDA, which benefits her consulting career by giving her insight into their expectations. Tracey’s strong analytical skills enable her to develop innovative strategies that tackle complex challenges. Committed to mentoring quality professionals, she fosters excellence in regulatory compliance globally. Known for her flexibility and calmness, she thrives in busy environments, skillfully leading diverse teams and handling cultural differences. Her career shows a strong commitment to helping others in the complex world of regulatory compliance.
DAY 1: June 5th, 2025
SESSION: Manual Visual Inspection Method Qualification
◆ Risk Assessment.
◆ Evaluation of Historical Data / Trending.
◆ Defect Catalog, Library.
◆ Container Challenge Sets.
◆ Probability of Detection and Interpretation of Results.