Register a second person and receive 5% off of your total course-fee immediately!
This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and GDP requirements. The course is meant for people employed in a GDP environment and provides an annual refresher on the most important GDP requirements.
Anyone employed in a GDP environment
08:30 - 09:00
Registration & coffee
09:00 - 12:00
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.
Basic Principles Everyone Needs to Know about GDP
The scope and applicability of GDP
The key areas of the new GDP - 10 chapters:
learn what is considered and impacted by this legislation
How GDP Guidelines Impact your Function
Your role in GDP
Why to follow GDP
Expectations of the GDP Inspectorates
General regulatory expectations for implementation
Common GDP deficiencies resulting in findings
Good Documentation Practice
What you must document
How to document
Special attention to: traceability, complaints, returns, recall, stolen goods and suspected falsified products
Exercises on practical implementation of GDP in daily activities