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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. You learn about the development and maintenance of a GDP Quality System during this course.
Audience
Anyone involved in development and maintenance of a GDP Quality System
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
Price
€ 699
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
Definition and Expectations
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The scope and applicability of GDP
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Overall aim
Legal Framework: EU Guidelines
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What you should know about EU guidelines
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History GDP guidelines
Quality System Components, get started & Set-up
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Definition, components, get started & set-up
GDP Requirements and how to implement them
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Quality Management explored in detail
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Obtain basic knowledge on:
o Personnel
o Premises and Equipment
o Documentation
o Operations
o Complaints, Returns & Suspected falsified MP’s
o Product Recalls
o Outsourced activities
o Self-inspections
o Transportation
o Brokers
The Importance of Procedures and Work Instructions
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Why?
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Who?
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Connecting three key elements
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Quality Manual
Role and Responsibilities Organization’s Management
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Quality System
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Responsible person
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Managerial Responsibilities
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Review and monitoring
Continuous Improvement
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How you can measure the effectiveness of a Quality System?
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How to take decisions?
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How can you improve a Quality System?
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Quality System Management in GDP
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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