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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 Medical Devices. The course aims to provide you with the guidance and tools to understand and implement the regulatory requirements for Medical Device Distribution in your daily activities.
Audience
Any function involved in Medical Devices Distribution activities
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
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.
Program
General Introduction to Medical Devices
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Applicable European legislation
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Definitions
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Medical Devices vs Medicinal Product
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Classification
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CE marking
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ISO 13485:2015 NEW!
Distribution License and Export
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Notification of distribution and export in your country, fees
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Export certificate and application
Good Distribution Practices
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Requirements for distribution
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How to achieve compliance with the regulatory requirements
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Competent authorities – how to handle an inspection
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What are the Quality System minimum requirements?
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Batch receipt and commercialization
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Deviations and CAPA Management
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Quality complaints and recall
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Counterfeit
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Change Control
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Risk Management
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Mix-up and cross-contamination prevention
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GDP Practical implementation and exercises
Materiovigilance
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What is materiovigilance?
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What needs to be notified, by whom and how?
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Contact Person responsibilities
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Workshop: Practical approach and exercises
Labelling Requirements
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Which materials should be reviewed
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Which requirement to follow