Essential GMP Skills​ - GMP Overview and an Introduction to the world of GxP

This one-day classroom course introduces key regulatory requirements and quality standards for employees in biotechnology, pharmaceuticals, and medical devices. It covers essential topics including documentation practices, quality control, validation, risk management, cleanliness, traceability, and the role of quality management systems (QMS) in advanced therapy medicinal product (ATMP) production.

Learning objectives:

• Understand key concepts and importance of GxP and GMP in ensuring product quality, safety, and compliance.
• Recognise the roles of major regulatory agencies (e.g., FDA, EMA) and the global regulatory framework.
• Learn core GMP practices: quality standards, traceability, documentation, and risk management.
• Understand how GMP applies across the full product lifecycle.
• Appreciate the importance of accurate documentation (batch records, SOPs).
• Recognize the need for trained personnel and GMP-compliant facilities/equipment.
• Understand personnel training requirements and facility/equipment qualification for GMP compliance.
• Learn how to identify, investigate, and address deviations, non-conformities, CAPA, change management, and the significance of fata integrity in GMP.

Who should attend:

Individuals new to biotherapeutics, ATMPs, or pharmaceuticals, as well as current professionals seeking a stronger grasp of regulatory production requirements and quality systems that safeguard patient safety.