A scientific & technical expedition through the world of vaccines and their dedicated therapies for human use.
This training course provides an overview of how to develop an optimized freeze-drying process, from freezing, primary and secondary drying to what is required to successfully move the cycle to scale-up for production.
This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.
This two-day course with workshop and case examples is designed for Managers and Sponsors of GLP and/or GCP Studies to develop a working knowledge of GLP and GCP requirements to support the implementation of the Quality Management System in a GLP and/or GCP setting.
In this course you will gain insight into the diversity of aggregates and particulates present in biopharmaceuticals revealed by new orthogonal methods.
This interactive training will provide essential insights to the key requirements for Data Integrity and Data Protection.
This course will bring critical insights into pricing and reimbursement processes, evaluations and requirements for digital health technologies in Europe and USA.
Three-day training focused on requirements and challenges in the characterization of biotherapeutics using bioassays and bioanalytics. Biostatistics, bioassay validation, and GCLP will be covered too.
This course is a compilation of topics representing recent challenges related to CSV, and how CSV relates to data integrity assurance. This course is meant to be an advanced course on selected modern CSV methods with special consideration of aspects playing into today’s omnipresent challenges around data integrity.
This practical course provides an in-depth understanding of operation, quality compliance & monitoring of pharmaceutical water. The series of case studies & discussions will bring clarifications on recent regulatory requirements, manufacturing, qualification, validation and data trending.