
cGMP training familiarizes personnel with the regulations and guidelines set forth by various regulatory agencies.
Training covers the principles of quality management systems (QMS) and how they apply to manufacturing processes, documentation practices, facilities, equipment, personnel, and materials. This includes understanding the importance of maintaining accurate records, conducting thorough investigations, and implementing corrective and preventive actions (CAPA) when deviations occur.
cGMP training emphasizes the importance of accurate and comprehensive documentation throughout the product lifecycle. This includes writing and maintaining standard operating procedures (SOPs), batch records, test protocols, validation reports, and other essential documents.
Training teaches individuals how to follow good documentation practices to ensure that records are legible, contemporaneous, attributable, original, accurate, and complete (ALCOA).
Training may include concepts related to risk assessment, risk analysis, and risk mitigation strategies as they pertain to product quality, safety, and regulatory compliance.
cGMP training promotes a culture of continuous improvement by encouraging personnel to identify opportunities for enhancing processes, reducing risks, and implementing best practices.
Individuals receive training on their specific roles and responsibilities within the cGMP framework, including understanding the impact of their actions on product quality and regulatory compliance.