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How to Write a Procedure That Works

1 Day
Auditing

This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and EU requirements concerning Good Documentation Practice with focus on the writing of procedures. The course focusses on the writing of a procedure that works in practice. Furthermore, records handling during production and/or distribution of medicinal, investigational and health products, and medical devices is highlighted.

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Audience

Anyone interested in the basic requirements and best practices on documentation writing (procedures) and electronic record keeping

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
Price
€ 899

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

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

How to write a Procedure

  • Standard Operating Procedure (SOP): presentation

  • Relevant stakeholders

  • SOP structure

o Purpose

o Scope

Abbreviations and definitions

o Process

o Documentation

o Revision history

o References

  • Tips & tricks

o Template

o Consistency

o Review metrics

o Process testing

o Risk assistent process

o Flow diagram

  • Finalization, implementation, review & adaptations

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How to Write a Procedure That Works

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Quastion Learning Center

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

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