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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.
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
Kristina Bindus
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Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.
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Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.
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Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.
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Kristina is specialized in online medical communication: webcast, webinar and e-learning.
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She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.
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Kristina has an extensive experience in Quality & Pharmacovigilance.
- 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
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Learn which activities need to be recorded and retained
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How to establish a Document Management process
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How to record to be compliant
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Documents access and security
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Workshop: Design a Documents Management SOP in GDP or GMP environment
How to write a Procedure
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Standard Operating Procedure (SOP): presentation
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Relevant stakeholders
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SOP structure
o Purpose
o Scope
o Abbreviations and definitions
o Process
o Documentation
o Revision history
o References
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Tips & tricks
o Template
o Consistency
o Review metrics
o Process testing
o Risk assistent process
o Flow diagram
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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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