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Critical thinking in CSV, think about it

Progress can organize a mock inspection and effectively train your employees for this

Case Study: Temporary replacement of QA officer during maternity leave ensured continuity and stability

Case Study: Implementation of a Large-Scale Validation Process at a Biotech Company

pharma

Operator Exposure Reduction – Strategies to the Shielding Solution

Case Study: Facility Shutdown Management

Efficient and Timely Batch Review

Case Study: Realization of an Effective Ongoing/Continued Process Verification System

Case Study: Realization of an Effective Ongoing/Continued Process Verification System

Conceptual designs for ATMP facilities

Case Study: Technology Transfer of Medical Device Production Processes

Case Study: Structural Improvement of Quality Management System

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

Case Study: Meeting the GAP III Program Requirements for a New QC and Research Lab at Bilthoven Biologicals

What are ATMP process development opportunities?

What do inspectors find in ATMP production facilities?

Implementing Pharmaceutical Regulatory Requirements in a Medical Device-oriented Quality Management System

The Four Phases of Transitioning from Paper to Electronic

Quality Control – Investigation Process flow

ATMP Manufacturing Risks

lean six sigma

The visual factory – a Lean project

Where do the ATMP RA/CMC challenges arise?

Internal Progress ATMP training 2023

Thilo Buck has won the 2022 Greiner Award for his thesis

Notes on Annex-1
(Part four)

ATMP therapy

The transfer of a new ATMP production line

Cleaning Validation Masterclass 2022

Event summary: Cleaning Validation Masterclass 2022

New ICH M10 “Bioanalytical Method Validation and Study Sample Analysis”

Notes on Annex-1
(Part three)

Abbott case Indra Scheen

Project management for Influenza Vaccine development

Engineering: Complete project life cycle

Case Study: Development and Manufacturing for Phase 1 Clinical Trial

Quality and Ethical considerations for Advanced therapy medicinal products

Notes on Annex-1 (Part two)

ATMP therapy

ATMP therapy: a collaboration between a biotechnological company and a hospital

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

Roles and Responsibilities of the Responsible Person (RP) and designated person

Working in multi-disciplinary teams

Progress website afbeeldingen

Cleaning validation of a multi-product production line

Notes on Annex-1 (Part one)

CMC Lead at CEPI

CMC lead at CEPI

Responsibilities of a qualified person

ATMP therapy

Case study: Technology Transfer of a newly developed vaccine process

Impact of cultural differences between the sending and receiving site

Progress website afbeeldingen

The art of Cleaning Validation

Experts in Life Sciences

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Bijlmermeerstraat 20
2131 HG Hoofddorp

023 563 5016
info@progress-lifesciences.nl

Leiden Office
BioPartner3 – office 3040
Galileiweg 8
2333 BE Leiden

023 563 5016
info@progress-lifesciences.nl

Copyright © 2019 – 2024 Progress – Experts in Life Sciences

Experts in Life Sciences

About us
Vacancies
Publications

Privacy statement

Expertises

CMC
Quality
Engineering and Qualification
ATMP

Contact

Head Office
Bijlmermeerstraat 20
2131 HG Hoofddorp

Leiden Office
BioPartner3 – office 3040
Galileiweg 8
2333 BE Leiden

023 563 5016
info@progress-lifesciences.nl

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