Agidens Academy

Discover the art of risk management and defect prevention with our FMEA training. Learn through practical exercises how to perform an effective FMEA step-by-step, essential for any professional aiming for excellence in quality management.

Why is calibration so crucial? Find out in our training that addresses the core questions of calibration: from the ‘what’ and ‘why’, to the ‘how’ and ‘who’. As the icing on the cake, we also offer practical examples.

This training provides in-depth knowledge about the correct validation of water and gas treatment systems, focusing on compliance and qualification of critical utilities. The ISPE Good Practice Guide on ‘Critical Utilities GMP Compliance’ is also covered extensively.

Explore the world of HVAC and its importance for climate-controlled spaces and buildings, specifically aimed at life science applications such as laboratories and cleanrooms. This training provides a solid foundation in HVAC principles and delves deeper into the climate control needs of specialized environments.

Understand the principles behind the energy transition and the role of heat pumps in the decarbonization process. This training provides insights into different types of heat pumps (air-water, water-water, and ground-water) and their industrial applications, essential for professionals aiming for energy efficiency.

Learn the importance of CTU qualification, regulations and guidelines from entities including the WHO, and the complete qualification procedure of IQ/OQ and PQ. This training also offers an overview of measurement systems for CTU qualification, crucial for quality assurance.

Dive into the world of SaaS application validation within cloud environments. Discover the role of cloud providers, how to avoid pitfalls, and best practices for validating software in the cloud.

Learn how to validate the integrity of system data using the ALCOA+ model, an essential skill for ensuring reliability and compliance in data management.

Understand the essence of sterilization, the calculation of process parameters, and the advantages and disadvantages of various sterilization practices and equipment. This training also delves into validation theory and practical methods for selected sterilization processes.

Dive into the world of pharmaceutical regulations and discover the essence of various legal requirements and their development. This training highlights the importance of different pharmacopoeias and teaches you how and where to find the relevant and most current texts. We challenge you to delve into the interpretation of complex texts, with special attention to the minimum requirements across multiple pharmacopoeias.

Gain insight into validating cleanrooms and associated regulations. Learn to identify critical elements, conduct tests such as smoke studies, particle counts, and filter integrity tests, and ensure accurate reporting and documentation.

This interactive training reveals the principles behind the qualification of analytical instruments, aligned with USP <1058> guidelines. We cover the lifecycle of instruments, from selection to maintenance, and delve into the required documentation and practical examples. This course is designed to guide you from the basics to advanced knowledge, enabling you to confidently work on the qualification of both simple and moderately complex equipment.

In this introductory and interactive method validation training, we unveil the secrets of the 5W’s (what, why, when, who, and which way), specific guidelines, and documentation intrinsically linked to the validation process. The concept of transfer validation is also covered from A to Z.

Discover the intricacies of cleaning validation and the associated legal frameworks in this practical training. We guide you through the entire process of conducting an effective cleaning validation. Learn to recognize critical elements, conduct essential tests correctly, and report findings.