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This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and GDP requirements for Quality Risk Management. The course aims to provide you with the guidance and tools to implement the GDP Quality Risk Management requirements into your business.
Audience
Anyone interested in Quality Risk Management and how this can be applied in GDP
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 12:00
Course
10:00 - 10:30
Networking & closing
Price
€ 399
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
Introduction
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What is Quality Risk Management?
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What is a risk?
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Basic definitions
Main Principles of Quality Risk Management
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The main principles of Quality Risk Management as described by ICH Q9 and WHO guidelines
Quality Risk Management Process
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Detailed explanation on the different phases of the process
Team and Decision Makers
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Who do you need in a Quality Risk Management team?
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What are the responsibilities of the decision makers?
Quality Risk Management in Practice
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How Quality Risk Management can be applied in practice
Workshop
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Detailed explanation on how to use the FMEA Tool with practical examples
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How to use the FMEA Tool
Participants about this course:
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Quality Risk Management in GDP
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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