Public courses

This tailor made training gives you the tools and skills required as Auditor or Lead Auditor in the Pharmaceutical and Medical Device industry.

- What are the requirements on legal manufacturers, to achieve CE-certification for in-vitro diagnostic devices? - What will the NB need look for when auditing our Quality Management System? - What is the responsibility of the PRRC, in relation to the QMS? This training will give you the answers!

Learn details for all part of the global cleaning validation strategy in pharmaceutical activities. CGMP expectations, technical and regulatory updates.

Experience Cleaning-in-Place (CIP) technology in action, incl. sustainability-focused cleaning processes, real-life trials, with experts in cleaning validation.

Learn the concepts of QMS software validation, how to assess risks related to QMS software and how to apply IQ, OQ and PQ to QMS software.

Training series contains 3 parts, half a day each.

1. Fundamentals of the IVDR and CE-marking of IVDs
2. IVDR – key elements of the risk classification and technical documentation for the CE-marking process.
3. IVDR Compliance: Demonstrating Performance and Safety for IVD Devices

What is “Normal” data? How do you know if your data are Normal? What do you do if your data are not Normal? Why would you care?

Learn about the IVDR and CE-marking of IVD medical devices. Understand the regulatory requirements for IVD medical devices. Understand the obligations under IVDR

Get tools and examples of best practice and learn how use the ‘Plan – Do – Check - Act approach’ to control and verify the performance of your suppliers.

What is risk? How does an organization identify and reduce it? This course provide a working knowledge and skills of the concepts and tools used in managing risk with applications to pharma and biopharma activities.

Learn how to apply design controls to ensure regulatory compliance for both hardware and software medical devices using agile development principles. This course covers ISO 13485, IEC 62304, EU MDR, FDA, risk management, SaMD, AI, and cloud-based technologies.

Learn the key requirements and how to maintain an efficient PMS system in compliance with the EU and US Medical Device regulations.

Learn about the new rule-based risk classification. Understand how the risk classification impacts on the conformity assessment route Learn about the general safety and performance requirements and how to demonstrate compliance Understand the structure and content of the Technical Documentation Understand how design changes to the product design impact on the technical documentation

Introduction to the regulatory requirements and guidelines related to manufacturing of pharmaceutical products and IVDs/Medical deviced, i.e. GMP and ISO 13485.

Learn about the new rule-based risk classification. Understand how the risk classification impacts on the conformity assessment route Learn about the general safety and performance requirements and how to demonstrate compliance Understand the structure and content of the Technical Documentation Understand how design changes to the product design impact on the technical documentation