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

This one-day, class-room-based training course provides introductory training that is important for employees in regulated industries like biotechnology, pharmaceuticals, and medical devices to ensure regulatory compliance, product safety, efficacy and quality of the product . The course provides a foundation for understanding regulatory requirements and quality standards that must be followed. Topics such as documentation practices, quality control, validation, risk management, cleanliness, traceability and the role of a quality management system (QMS) in advanced therapies medicinal product (ATMP) production are covered.

Learning objectives:

• Understand the definitions, concepts, and significance of Good x Practice (GxP) and Good Manufacturing Practice (GMP) in maintaining product quality, safety, and compliance in regulated industries.​
• Gain awareness of the regulatory agencies (such as the FDA and EMA) responsible for enforcing GMP guidelines and the global regulatory framework.​
• Learn the core principles of GMP, including adherence to quality standards, traceability, documentation, and risk management.​
• Understand how GMP principles apply across the product lifecycle, from research and development to manufacturing, distribution, and post-market surveillance.​
• Learn the importance of accurate and comprehensive documentation, including batch records and standard operating procedures (SOPs).​
• Understand the significance of personnel training, qualification, the design, qualification, and maintenance of GMP-compliant facilities and equipment.​
• Understand the importance of identifying, investigating, and addressing deviations, non-conformities, and implementing corrective and preventative action (CAPA) measures, change management and the significance of data integrity in GMP.

Who should attend:

Individuals new to highly regulated industries such as biotherapeutics, ATMPs, or pharmaceuticals, and those currently working within these sectors wishing to gain a better understanding of the foundations of strict regulatory production requirements and quality systems that always ensure patient safety.