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Quality System Management in GDP

1 Day
GDP

This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and GDP requirements. You learn about the development and maintenance of a GDP Quality System during this course.

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Audience

Anyone involved in development and maintenance of a GDP Quality System

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
Price
€ 699

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

  • 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.

Program

Definition and Expectations

  • The scope and applicability of GDP

  • Overall aim

Legal Framework: EU Guidelines

  • What you should know about EU guidelines

  • History GDP guidelines

Quality System Components, get started & Set-up

  • Definition, components, get started & set-up

GDP Requirements and how to implement them

  • Quality Management explored in detail

  • Obtain basic knowledge on:

o Personnel

o Premises and Equipment

o Documentation

o Operations

o Complaints, Returns & Suspected falsified MP’s

o Product Recalls

o Outsourced activities

o Self-inspections

o Transportation

o Brokers

The Importance of Procedures and Work Instructions

  • Why?

  • Who?

  • Connecting three key elements

  • Quality Manual

Role and Responsibilities Organization’s Management

  • Quality System

  • Responsible person

  • Managerial Responsibilities

  • Review and monitoring

Continuous Improvement

  • How you can measure the effectiveness of a Quality System?

  • How to take decisions?

  • How can you improve a Quality System?

Contact Quastion for more information about this Quality System Management in GDP 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 BV

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