Signal Management in Pharmacovigilance Videorecording
This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.
Artificial Intelligence & Cloud: Validation and Data Integrity in a BioPharma GxP Environment
This course is a compilation of topics representing recent challenges related to CSV of AI or cloud-based systems in a GxP regulated context, and how CSV relates to data integrity.
Cross-Contamination Risk Assessment in Pharma Manufacturing
The training will share approaches how systematic risk management of cross-contamination risks can be performed and implemented in the QA system.
Pharmacovigilance Inspections & Audits Updates
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.
Digital Quality in Clinical Trials
This unique course provides a practical & in-depth understanding of electronic systems and technologies used in clinical trials, and brings clarifications on global regulation, requirements, compliance & quality concerns.
Practical Decision Analysis for Drug Research & Development
This course is designed for drug R&D professionals who wish to develop their skills and knowledge in decision analysis, and to use these techniques to drive value and innovation.
Monoclonal Antibodies
This unique 3-day course is designed for advanced persons & specialists in the field of protein therapeutics or participants who have emphasis to jump into this exciting new business field.
Pharma Laboratory Digitalization & Automation
The need for digitalization in the pharmaceutical laboratories is continuously evolving & there is a need for a more unified approach to laboratory and data management.
Toxicology, ADME & Early Drug Development Plan
Building an Integrated Safety Testing Strategy based on ADME and Toxicology. The purpose of this Toxicology, ADME & Early Drug Development Plan is to understand the concept of a combined ADME-Toxicology approach.
Good Laboratory Practice & GCP for Laboratories
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 implementation of the Quality Management System in a GLP and/or GCP setting.
Clinical Trials Quality & Inspection Updates
This practical course provides an in-depth understanding of current and planned GCP requirements and their practical implications as well as insights into the current GCP inspection focus and hot topics.
Lyophilization in Pharma & Biotech
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.
Quality & Regulatory Requirements for Inhalation Drug Products
This course will cover the aspects of the human respiratory tract that are relevant to the delivery of medicines to the lungs.
Advanced Protein Aggregation & Characterization
This practical Advanced Protein Aggregation & Characterization course provides an insight into the diversity of aggregates and particulates present in biopharmaceuticals revealed by new orthogonal methods.
Stability & Shelf Life of Cell & Gene Therapy Products
This 2-day practical workshop is focused on ATMPs & brings a comprehensive overview on stability and shelf-life regulatory landscape, as well as analytical methods for stability assessment of your cell & gene therapy products.
Computerized Systems Validation, Data Integrity & Cloud Computing in Pharma & Biotech
This course is a compilation of topics representing recent challenges related to CSV of cloud-based systems in GxP regulated context, and how CSV relates to data integrity assurance.
Quality & Regulatory Requirements for Drug Device Combination Products in the UK & US
This interactive course will bring clarifications on quality & regulatory requirements for combination products in the UK & US.
Quality Requirements for Biotech Products
This practical course provides an in-depth understanding regulatory landscape for national CTA
procedures.
