Introduction to this course: 

This course explores key concepts, regulations, and guidelines regarding the structured approach of system validation/qualification activities: control strategy concepts, qualification process with V-model, and validation master plan.

Who should attend: 

This course is ideal for professionals in the pharmaceutical industry, including quality assurance specialists, regulatory affairs professionals, production managers, and validation engineers. It is also suitable for anyone involved in compliance, system validation, and qualification processes.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Identify key regulatory guidelines and GMP requirements for system validation and qualification.

• Explain the principles of system validation and qualification in pharmaceutical production.

What will I gain: 

Participants will gain a thorough understanding of system validation and qualification processes, ensuring compliance with EMA and FDA regulations. They will acquire knowledge to enhance quality assurance in pharmaceutical production systems.

Prerequisites: 

Basic knowledge of pharmaceutical production and regulatory standards is recommended. Familiarity with quality assurance concepts and GMP guidelines will be beneficial.

Additional information: 

Course duration: 00:16:52

Course code/version (effective date): L-121/v1.0 (1/06/2023)