Publications - Progress

Articles & Case Studies

Case Study: Galapagos – QMS Backlog Reduction and System Transition

Tom

Case Study: Interim QA Manager Ensures Seamless Oversight Across Multiple CDMO/CMO Sites

Arunava Ghosh

Regulatory Landscape and the Evolution of Contamination Control in 2025

Thilo Buck

Case Study: Rules and regulations within the radiopharmaceutical industry

Thilo Buck

The Role of the Qualified Person (QP) in the Pharmaceutical Industry

Cor Marsman

Impact of cultural differences between the sending and receiving site

Theresa Derksen

Engineering and CQV

Case Study: Cleaning validation of a multi-product production line

Michelle Langeslag

Engineering and CQV

Critical thinking in CSV, think about it

Hans de Koning

Advancing Gene Therapy: Updates from the European Pharmacopoeia

Thijs Booiman

Case Study: Temporary QA support maintains stability during leave

Elvira van Straten

Engineering and CQV

Case Study: Large-scale validation process implemented at biotech company

Marco Albrecht

Engineering and CQV

Case Study: Facility Shutdown Management

Christophe Mombers

Efficient and Timely Batch Review

Cor Marsman

Case Study: Ongoing process verification successfully implemented

Michel Brik Ternbach

Engineering and CQV

Case study: Operator Exposure Reduction – Strategies to the Shielding Solution

Danny Bouwhuis

Engineering and CQV

Case Study: Technology Transfer of Medical Device Production Processes

Michelle Langeslag

Case Study: Structural Improvement of Quality Management System

Sonja van den Oudenrijn

Engineering and CQV

Case Study: C&Q lead for a new auto-injector assembly line

Rob Severijnse

Engineering and CQV

Case Study: Meeting GAP III requirements for new QC and research lab

Klaas Geveke

What are ATMP process development opportunities?

Thilo Buck

What do inspectors find in ATMP production facilities?

Thilo Buck

Case Study: Conceptual designs for ATMP facilities

Christophe Mombers

Case Study: Implementing pharma regulations in a medical device QMS

The Four Phases of Transitioning from Paper to Electronic

Mischa van Hout

Case Study: Quality Control – Investigation Process flow

Floris Janse de Jonge

Engineering and CQV

Case Study: The visual factory – a Lean project

Marieke van den Bosch

Where do the ATMP RA/CMC challenges arise?

Thilo Buck

Internal Progress ATMP training 2023

Thilo Buck has won the 2022 Greiner Award for his thesis

Thilo Buck

Notes on Annex-1
(Part four)

Cor Marsman

Case Study: The transfer of a new ATMP production line

Dennis Wortel

Event summary: Cleaning Validation Masterclass 2022

Paul Tiemeijer

Bioanalytical method and sample analysis under ICH M10

Notes on Annex-1
(Part three)

Cor Marsman

Case Study: Project management for Influenza Vaccine development

Indra Scheen

Engineering and CQV

Engineering: Complete project life cycle

Rene

Case Study: Development and Manufacturing for Phase 1 Clinical Trial

Michel Brik Ternbach

Quality and ethics in advanced therapy medicinal products

Cor Marsman

Notes on Annex-1 (Part two)

Cor Marsman

ATMP therapy collaboration between biotech and hospital

Activities in pharmaceutical development – Finding the balance. What to do when?

Roles and responsibilities of the responsible person and designated person

Cor Marsman

Working in multi-disciplinary teams

Rene Huinen

Notes on Annex-1 (Part one)

Cor Marsman

Case Study: CMC lead at CEPI

Engineering and CQV

Mastering the Art of Cleaning Validation

Paul Tiemeijer

Case Study: Technology Transfer of a newly developed vaccine process

Theresa Derksen