Register a second person and receive 5% off of your total course-fee immediately!

Good Quality Management Practice in GMP/GDP

1 Day

This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and GMP/GDP/ICH requirements to Quality Systems. The course aims to provide you with the guidance and tools on how to develop and implement a robust and effective Quality System tailored to your organization.

Quastion LogoWhite.png

Anyone interested in or responsible for GMP/GDP/ICH requirements into Quality Systems. Especially functions involved in Quality Systems and Quality Management, and job functions like the QP and RP & GDP

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
€ 799

per participant    (excl. VAT)

✓ Exclusive learning approach

✓ Personal course documentation

Lunch, water, coffee & tea


✓ Course certificate after completion


Quastion Learning Center (Qplus consult BVBA)

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

Your Trainer

Kristina Bindus

  • Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.

  • Co-founder of and Belgian internet radio Singjaal.

  • Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.

  • Kristina is specialized in online medical communication: webcast, webinar and e-learning.

  • She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.

  • Kristina has an extensive experience in Quality & Pharmacovigilance.


Basic GMP/GDP/ICH Requirements to Quality System

  • Quality System in practice

  • GMP requirements to Pharmaceutical Quality System

  • GDP requirements to Quality System 

  • ICH Q10 Pharmaceutical Quality System 

  • Continuous improvement 

  • The role of management

How to Apply in an efficient and effective Manner:

Quality System - Quality Risk Management – Deviation and CAPA management – Investigations and Root Cause Analysis

  • Manufacturing

  • Distribution

  • Crucial success facts

  • Quality Risk Management: ICH guideline Q9, tools and tips 

  • Deviation and CAPA Management 

  • Investigation and Root Cause Analysis

  • Basic principles for continuous improvement 

  • Root Cause Analysis methods, efficient tools and tips 

  • Human error

How to get the complete Circle working: Continuous Improvement


  • Workshop: Effective Quality System development

How to improve and simplify your Quality System

  • Tips to simplify any Quality System

  • Tools to have a process in place for Quality System improvement

Participants about this course:
Contact Quastion for more information about this Good Quality Management Practice in GMP/GDP training.
Other courses you might be interested in:

On demand

Good Documentation Practice in GMP and GDP

1 Day

Heading 6

+32 (0) 2 899 05 68

Email Icon.png
KF location icon.png

Leuvensesteenweg 643 bus 7

1930 Zaventem


TAV: BE 0822 940 179

Quastion Logo white.png

a division of

Qplus consult BV

Email Icon.png
LinkedIn Icon.png

© 2010 - 2020 All Rights Reserved | Quastion