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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. The course is meant for people employed in a GDP environment and provides an annual refresher on the most important GDP requirements.
Audience
Anyone employed in a GDP environment
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
Basic Principles Everyone Needs to Know about GDP
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The scope and applicability of GDP
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The key areas of the new GDP - 10 chapters:
learn what is considered and impacted by this legislation
How GDP Guidelines Impact your Function
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Your role in GDP
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Why to follow GDP
Expectations of the GDP Inspectorates
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General regulatory expectations for implementation
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Common GDP deficiencies resulting in findings
Good Documentation Practice
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What you must document
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How to document
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Special attention to: traceability, complaints, returns, recall, stolen goods and suspected falsified products
Workshops
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Exercises on practical implementation of GDP in daily activities
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Good Distribution Practice: Refresher Course
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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