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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. It aims to provide you with the guidance and tools to understand and implement GDP in your daily activities.
Audience
This course is designed for Management only
Time Schedule
08:00 - 09:00
Registration & coffee
09:00 - 10:00
Session
10:00 - 10:30
Networking & closing
Price
€ 47
per participant (excl. VAT)
✓ Exclusive learning approach
✓ Personal session documentation
✓ Breakfast, water, coffee & tea
✓ Networking
✓ Attendance notice
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
How GDP Guidelines impact your Function
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Your role in GDP
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Why to follow GDP
What GDP Compliance means for you
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Is GDP applicable to everyone working in GDP environment?
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Learn the framework of your role and responsibilities
Implementation of the new EU GDP Guideline
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How to get started with implementation of the new GDP
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How to develop and implement an effective Quality Management System
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Role and responsibilities of the RP
How each Function can Apply Risk Management in GDP
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How to detect, assess and document the Risks
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How to reduce the identified Risks
Expectations of the GDP Inspectorates
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General regulatory expectations for implementation
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Common GDP deficiencies resulting in findings
Which Training you have to complete to be GDP-conform
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How to develop an efficient and sufficient GDP Training Plan
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How to show the effectiveness of the GDP training
Why care about Temperature-controlled Distribution
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What is your role in ensuring that the quality and integrity of products is not compromised?
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Good Distribution Practice for Management
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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