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Medical Devices Distribution

1 Day
Life Sciences

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.

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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

Program

General Introduction to Medical Devices

  • Applicable European legislation 

  • Definitions

  • Medical Devices vs Medicinal Product

  • Classification

  • CE marking

  • ISO 13485:2015 NEW!

 

Distribution License and Export

  • Notification of distribution and export in your country, fees

  • Export certificate and application

 

Good Distribution Practices

  • Requirements for distribution

  • How to achieve compliance with the regulatory requirements

  • Competent authorities – how to handle an inspection

  • What are the Quality System minimum requirements?

  • Batch receipt and commercialization

  • Deviations and CAPA Management

  • Quality complaints and recall

  • Counterfeit 

  • Change Control

  • Risk Management

  • Mix-up and cross-contamination prevention

  • GDP Practical implementation and exercises

Materiovigilance

  • What is materiovigilance?

  • What needs to be notified, by whom and how?

  • Contact Person responsibilities

  • Workshop: Practical approach and exercises

Labelling Requirements

  • Which materials should be reviewed

  • Which requirement to follow

Participants about this course:
Contact Quastion for more information about this Medical Devices Distribution training.
 
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+32 (0) 2 899 05 68

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Leuvensesteenweg 643 bus 7

1930 Zaventem

Belgium

TAV: BE 0822 940 179

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a division of

Qplus consult BVBA