Managing Nonconformities in Pharmaceutical Laboratories (Classroom)

Event

Course Description:

This course provides detailed guidance on managing nonconformities (NCs) in laboratory operations, including both procedural- and results-related issues. The first session introduces key terms and definitions, along with ISO and WHO requirements. Participants will learn how to classify NCs, write NC statements, and conduct investigations to resolve issues effectively.

The second session focuses on applying Root Cause Analysis and Corrective and Preventive Actions to address NCs. The final session covers the investigation of Out-of-Specification results, emphasizing a systematic approach to ensure the reliability and validity of laboratory outcomes.

Pricing varies. Please inquire for more info at https://go.usp.org/Services.

Upon completion of this course, you will be able to

  • Define key terms related to NCs.
  • Manage NCs in laboratory work and results effectively.
  • Apply a systematic approach to identify, document, and resolve NCs to ensure reliable laboratory results.
  • Consistently address NCs related to laboratory activities and test outcomes.

Who should participate:

  • National and private QC laboratories (PC, MB, Clinical, etc.)
  • Manufacturers