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GDP Refresher: Good Documentation Practice

Half-day
GDP

This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and EU requirements. This course gives you an overview of basic documentation requirements regarding procedures and the handling of records during production and/or distribution of medicinal, investigational and health products, and medical devices.

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Audience

Anyone interested in the basic requirements and best practices on documentation and electronic record keeping

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 12:00
Course
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

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

GDP/GMP Good Documentation Practice

  • Learn which activities need to be recorded and retained

  • How to establish a Document Management process

  • How to record to be compliant

  • Documents access and security

  • Workshop: Design a Documents Management SOP in GDP or GMP environment

Contact Quastion for more information about this GDP Refresher: Good Documentation Practice 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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