Public courses

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

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 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

Learn how valid statistical techniques contribute to Process Validation efforts. Best practices for quality systems in industry.

Learn how valid statistical techniques contribute to Process Validation efforts. Best practices for quality systems in industry.

Lär dig att förstå, navigera, tolka och tillämpa GMP enligt krav i både EU och USA, samt ICHs guidelines för kvalitetssystem och kvalitetsriskhantering.

Get a good insight and understanding of the key requirements for a risk management system in compliance with EU regulations.