The validation and qualification of equipment, systems, and processes are central requirements in a GMP-regulated environment. The EU GMP Guide and Annex 15 define clear expectations for planning, execution, and documentation that must be implemented in a transparent and traceable manner in practice.
The intensive training provides a comprehensive overview of the fundamental requirements for validation and qualification and demonstrates their practical implementation within an operational environment. The focus is on equipment qualification and process validation throughout the entire lifecycle—from initial planning and execution to maintaining the validated state.
A key focus is the risk-based approach as required by current regulatory guidelines. The training explains how risk assessments can be effectively applied to plan and carry out qualification and validation activities efficiently without compromising GMP compliance.
In addition, the requirements for documentation within the validation framework are addressed. Participants learn which documents are required, how they should be structured, and what expectations regulatory authorities have regarding clear, traceable, and auditable documentation.
The integration of requalification and revalidation into existing systems is also covered. This includes how changes are assessed and which measures are necessary to ensure the validated state is consistently maintained.
Another component of the training is inspection readiness. Participants gain insight into how validation systems are evaluated and what typical expectations inspectors have regarding implementation.
The seminar is designed for professionals from quality assurance, production, and technical departments who are involved in the planning, execution, or assessment of qualification and validation activities.
Through its structured and practice-oriented approach, the intensive training supports participants in reliably implementing regulatory requirements and ensuring that validation processes within the company are clear, compliant, and efficiently managed.