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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.
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
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
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
Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.
Co-founder of Webcaststudio.be 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
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
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
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