Certificate "GMP Officer in Analytical Laboratory"

Target Audience

– Employees in Quality Control
– Laboratory Managers
– Heads of Quality Control
– Qualified Persons (QP)
– Employees in Quality Assurance

Learning Objectives

Pharmaceutical quality control laboratories are regularly the focus of regulatory inspections. After FDA inspections, many lab-specific deficiencies are found in 483 findings and warning letters.

The FDA's Compliance Program Guidance Manual highlights the following areas as key points during laboratory inspections:

– Calibration and qualification of analytical equipment
– Reference standards
– GMP-compliant documentation
– Retention samples
– Stability program
– Validation of computer systems
– Training

All these key topics are addressed in this seminar, with the most important subjects further explored in workshops. The goal is to provide a comprehensive overview of the main GMP requirements for quality control, from both European and US (FDA) perspectives. Participants will learn how to confidently implement these requirements and will receive documentation examples for practical application.