Who Should Attend

This two-day course is designed for those who perform, supervise, manage, audit, or oversee the qualification and calibration of Quality Control Laboratory instruments in a GMP setting. Instrumentation includes that which is used for small molecule pharmaceuticals, biopharmaceuticals, and biologics. 

The course is oriented towards, but is not limited to, Quality Control Laboratory Analysts, Quality Control Laboratory Supervisors, Analytical Development professionals, Quality Assurance professionals, and Metrologists in a GMP setting.  The course will also benefit those in other departments who find instrument qualification and calibration among their responsibilities.



Learning Objectives

Upon completion of this course, attendees will have a clear understanding of regulatory agency expectations and will have gained the background knowledge necessary to successfully plan and carry out effective instrument calibration and qualification procedures for a wide variety of instruments used in the typical QC laboratory.  Attendees will develop expertise in:

• Identifying critical calibration parameters
• Writing calibration procedures
• Documenting calibration results
• Setting acceptance limits for calibrations using risk-based approaches 

Attendees will also gain an understanding of compliant versus non-compliant practices in calibration activities through discussion of real-life examples of deficiencies found during regulatory audits.

Course Description

This course will provide a comprehensive introduction to the qualification and calibration of laboratory instruments used for the analysis of pharmaceutical products.  It will emphasize guidance from US and international sources and the use of this knowledge to identify critical calibration parameters and acceptance limits based on rational, risk-based analysis.

The course will also highlight important points to assure regulatory compliance, the significance of well-planned protocols and documentation of results and how to prepare for regulatory audits of calibration activities in the QC laboratory.  There will be discussion of real-life situations regarding non-compliant calibrations found during regulatory audits, and the opportunity to address specific calibration issues raised by attendees in a roundtable format.

As time permits, participants will also have the opportunity for one-on-one consulting with the course director who has over 30 years of FDA experience.