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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.
Audience
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)
10:00 - 10:30
Networking & closing
Price
€ 799
per participant (excl. VAT)
✓ Exclusive learning approach
✓ Personal course documentation
✓ Lunch, water, coffee & tea
✓ Networking
✓ Course certificate after completion
Location
Quastion Learning Center (Qplus consult BVBA)
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
Your Trainer
Kristina Bindus
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Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.
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Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.
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Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.
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Kristina is specialized in online medical communication: webcast, webinar and e-learning.
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She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.
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Kristina has an extensive experience in Quality & Pharmacovigilance.
- Kristina Bindus has over 25 years of experience in QA, RA, Auditing and Pharmacovigilance within leading (bio)pharmaceutical and medical devices companies.
Program
Basic GMP/GDP/ICH Requirements to Quality System
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Quality System in practice
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GMP requirements to Pharmaceutical Quality System
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GDP requirements to Quality System
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ICH Q10 Pharmaceutical Quality System
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Continuous improvement
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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
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Manufacturing
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Distribution
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Crucial success facts
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Quality Risk Management: ICH guideline Q9, tools and tips
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Deviation and CAPA Management
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Investigation and Root Cause Analysis
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Basic principles for continuous improvement
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Root Cause Analysis methods, efficient tools and tips
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Human error
How to get the complete Circle working: Continuous Improvement
Workshop
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Workshop: Effective Quality System development
How to improve and simplify your Quality System
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Tips to simplify any Quality System
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Tools to have a process in place for Quality System improvement
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Good Quality Management Practice in GMP/GDP
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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