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Quality Risk Management in GDP

Half-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 Quality Risk Management. The course aims to provide you with the guidance and tools to implement the GDP Quality Risk Management requirements into your business.

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Audience

Anyone interested in Quality Risk Management and how this can be applied in GDP

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
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Kristina Bindus

  • Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.

  • Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.

  • Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.

  • Kristina is specialized in online medical communication: webcast, webinar and e-learning.

  • She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.

  • Kristina has an extensive experience in Quality & Pharmacovigilance.

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    Kristina Bindus has over 25 years of experience in QA, RA, Auditing and Pharmacovigilance within leading (bio)pharmaceutical and medical devices companies.
Program

Introduction

  • What is Quality Risk Management?

  • What is a risk?

  • Basic definitions

Main Principles of Quality Risk Management

  • The main principles of Quality Risk Management as described by ICH Q9 and WHO guidelines

Quality Risk Management Process

  • Detailed explanation on the different phases of the process

Team and Decision Makers

  • Who do you need in a Quality Risk Management team?

  • What are the responsibilities of the decision makers?

Quality Risk Management in Practice

  • How Quality Risk Management can be applied in practice

Workshop

  • Detailed explanation on how to use the FMEA Tool with practical examples

  • How to use the FMEA Tool

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Quastion Learning Center

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

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