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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.
Anyone interested in the basic requirements and best practices on documentation writing (procedures) and electronic record keeping
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
per participant (excl. VAT)
✓ Exclusive learning approach
✓ Personal course documentation
✓ Lunch, water, coffee & tea
✓ Course certificate after completion
Quastion Learning Center (Qplus consult BVBA)
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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.
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
o Abbreviations and definitions
o Revision history
Tips & tricks
o Review metrics
o Process testing
o Risk assistent process
o Flow diagram
Finalization, implementation, review & adaptations