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.
The goal of this course is to prepare attendees who want to pursue the Nursing Case Management Certification Exam by the American Nurses Credentialing Center.
The course will be illustrated with many real examples: from areas of pilot and scale up of chemical synthesis, transfer of finished dosage forms from Pharmaceutical Development to Production and the transfer of analytical methods from R&D to QC.
This course is designed for R&D project managers working in the Pharmaceutical Industry. It will create awareness and a basic understanding of Agile and how it can be helpful for Pharma R&D project management. Join us & learn about classical R&D project management and applying agile thinking to Pharma R&D such as Portfolio Kanban.
This course will provide a comprehensive, yet practical guide to pharmacovigilance audits and inspections best practice to help navigate what is required to demonstrate compliance.