The course aims to explain the complex nature of viruses that move between the concepts of life and death. It provides participants with a fundamental understanding of viral and pathogen safety in the pharmaceutical industry. Participants will acquire basic knowledge of virology, including the physiology of viruses, their replication cycles, transmission routes and resistance mechanisms. This knowledge is essential for risk assessment and the development of safety strategies.
In addition, the programme teaches advanced safety strategies for dealing with viruses and testing methods, including NGS (next generation sequencing) and other modern diagnostic methods. Participants will learn best practices for viral inactivation and validation to ensure products meet industry requirements and global regulatory frameworks such as ICH Q5A, the European Medicines Agency (EMA) and the European Pharmacopoeia.
The course also provides practical insights into the control of viral contamination, including risk mitigation strategies through facility segregation, risk analysis and contamination risk management. Finally, advanced virus detection methods, including NGS, and safety-related aspects of Advanced Therapy Medicinal Products (ATMP), such as gene and cell-based therapies, will be highlighted.
Background
The past has shown us that the development and production of vaccines can also attract enormous public attention. This makes it all the more important, especially when it comes to approval and production under time pressure, that the quality standards of good manufacturing practice are observed.
Virus safety is one of the major concerns in the development and production of biopharmaceuticals and biologics. Huge efforts are undertaken to prevent viral contamination. A series of guidelines was dedicated to that topic exclusively.
For many people who are involved in the development and production of biopharmaceuticals and biologics the world of viruses is a “black box”.
Target Group
This Education Course is directed to responsible personnel involved in the development and production of biopharmaceuticals and biologics
Research & Development
Quality Assurance
Regulatory Affairs
Production
Engineering
Quality Control
It is also useful for service providers, such as contract research organisations and contract manufacturers.
Date & Venue
Date Tuesday, 03 March 2026, 08.30 - 17.30 h (Registration and Coffee 08.00 - 08.30 h) Wednesday, 04 March 2026, 08.30 - 16.30 h
Venue Qube Hotel Bahnstadt Grüne Meile 21 69115 Heidelberg, Germany Phone: +49 (0) 62 21/18 79 90 bahnstadt@qube-heidelberg.de
EU legislation / EMA note for guidance / reflection paper
EDQM TSE Certification
Interactive Workshops with Case Studies and Examples
During these workshops, the participants develop in small groups approaches to manufacture pathogen safe products, e.g. choosing testing strategies and calculating safety margins.
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager" Learn more
Testimonials
Seminar Programme as PDF