Laboratory Investigations Course

Understanding how to properly manage unexpected, atypical, or out-of-trend laboratory results is a critical skill for professionals working in regulated pharmaceutical environments. This comprehensive course provides participants with the scientific, procedural, and regulatory foundations required to execute laboratory investigations effectively and in compliance with international quality standards.

Throughout the course, attendees will learn how to identify and classify different types of laboratory investigations, perform structured root-cause analysis, and document findings according to GxP expectations. You will gain hands-on insight into deviation management, OOX (Out-of-Specification/Out-of-Trend) reports, trending analysis, and corrective and preventive actions (CAPAs). Additionally, the program focuses on establishing robust communication channels with regulatory authorities and implementing continuous improvement strategies to reduce recurrence.

The course combines theoretical instruction with real case studies, providing practical tools to strengthen laboratory data integrity, ensure consistent product quality, and support audit-readiness. Upon completion, participants will be able to confidently lead or contribute to investigation workflows and ensure that critical results are scientifically justified and fully compliant with regulatory guidelines.

Regulatory references: ICH Q7, Q9, Q10, EU-GMP, EMA, FDA, WHO.

Languages available: English, Dutch.

Certificate of attendance provided.