Quality & Regulatory Requirements for Drug Device Combination Products in the EU
This course will cover the definition of combination products, EU regulatory pathways, and will explain the current state of developments as medical device manufacturers and marketing authorisation holders prepare for the new requirements.
BA/BE, Dissolution & Biowaivers
This course will evaluate every aspect of BA/BE from the regulations and types of protocol studies to bioanalysis, statistical analysis and reporting.
Bioassays & Bioanalytical Methods
This practical Bioassays and Bioanalytical Methods online live training is focused on complex therapeutics, such as Biopharmaceuticals, Biologics and Biosimilars.
CCUS Well Design and Monitoring
This 4 half-day master-class workshop will provide a comprehensive review of integrity of wells exposed to carbon dioxide (CO2) in the context of Carbon Capture Utilization – for enhanced oil recovery – and Storage (CCUS).
Materials Selection and Corrosion Control for CCS Wells
This 3-day workshop focuses on material selection for new or existing wells that are used to inject and monitor CO2 as part of Carbon Capture Utilization – for enhanced oil recovery – and Storage (CCUS) projects.
Immunogenicity of Biologics, Biopharmaceuticals & ATMPs
This unique course provides a practical & in-depth understanding of immunogenicity risk assessment and risk minimization.
Signal Management in Pharmacovigilance
This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.
Effective Project Management for Clinical Trials
This course will focus on honing the skills for excellent Clinical Project Management.
Relief & Flare Systems
The course covers relief, flare and vent systems design. It describes why specific equipment like separators and heat exchangers require relief protection and how to determine the relief cases for these items.
Control Valves & Actuated On/Off Valves
This practical course provides an in-depth understanding of polymorphic and multi-component systems.
Hydrogen Storage, Material Issues and Inspection Techniques
This course provides an in-depth exploration of hydrogen storage systems, focusing on material selection, degradation mechanisms, and inspection techniques.
Extractables & Leachables Analysis
Since its inception the topic of extractables and leachables has grown continuously. It has expanded into different dose forms and heighted regulatory expectations.
Market Access for Digital Health Technology
This hands-on workshop is designed to provide practical, real-world experience in navigating the regulatory, reimbursement, and market access challenges for digital health apps.
Fiscal Metering & Custody Transfer
This three-day course provides an overview of the key aspects of a metering station designed for fiscal metering or custody transfer.
Computerized Systems Validation & Data Integrity in Pharma & Biotech Videorecording
This course is a compilation of topics representing recent challenges related to CSV, and how CSV relates to data integrity assurance.
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.
Advanced RBI for Process Industry
This course will provide inspectors and analysts with advanced knowledge and skills in Risk-Based Inspection (RBI) based on the framework defined in API RP 580 and an in-depth understanding of the calculations performed according to the API RP 581 for fixed equipment and piping.
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.
