13 – 15 October 2026
TRAINING TIMES
Understand industry approaches for Scale-up, Tech Transfer and PV applying QbD principles.
Quality Risk Management: definition, importance and examples.
Overview of main tech transfer challenges for sterile products with practical examples.
Current trends, challenges and developments in sterile manufacturing.
Three days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
Risk and science based development: How to apply ICH Q9 principles
Planning and execution: integration of ICH concepts and elements of tech transfers
CCS, RABS and isolators, CMO and CDMOs, single use technologies
Preparation of a buffer for a vaccine: evaluation of mixing. Risk assessment for a lyophilised and liquid formulation
The importance of aseptic process simulations. Annex 1 and its influence on aseptic operations
The 3 stages of process validation: work packages and deliverables. EMA and FDA PV guidances.
Designed for professionals who want to enhance their expertise and advance their careers
Protea, CEO
Laura has extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements. This includes writing and revision of CMC regulatory documentation for the drug substance and drug product used in veterinary and human hormonal therapy, antibiotics, statins, vaccines and over-the-counter medications. Laura’s experience brings a unique combination of scientific background and effective communication skills that are well-matched with her international perspective and experience. She was responsible for the outsourcing of all analytical and processing activities related to the development, scale-up, tech transfers and validation of pharmaceutical products within multidisciplinary teams managing in DSM, Janssen and Disphar. Laura also has in-depth and direct experience in collaborating and managing CROs and CMOs in culturally diverse environments, mostly within Europe and Asia (especially India and China). She is certified as an independent ICH-GCO and GLP auditor in clinical trials.
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“This course was enlightening in understanding how quality isn't a post-hoc check, but the result of rigorous scientific planning. It provided me with the mental tools to connect every single production step—from buffer preparation to freeze-drying—directly to patient safety. An essential learning experience for anyone working in the sterile sector.”Guido Di Stasio
“Laura has a strong process knowledge and has been instrumental in enhancing understanding of the overall approach to process scale-up and process validations.”Yashwanth Gnaneswara Rao
“Highly valuable content. Great overview combined with great technical knowledge. Concrete and solid knowledge was shared in an easy to understand format - highly appreciate it. ”Ana Clara De Carvalho Stelmach
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