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This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and GDP requirements. You learn about the development and maintenance of a GDP Quality System during this course.
Anyone involved in development and maintenance of a GDP Quality System
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.
Definition and Expectations
The scope and applicability of GDP
Legal Framework: EU Guidelines
What you should know about EU guidelines
History GDP guidelines
Quality System Components, get started & Set-up
Definition, components, get started & set-up
GDP Requirements and how to implement them
Quality Management explored in detail
Obtain basic knowledge on:
o Premises and Equipment
o Complaints, Returns & Suspected falsified MP’s
o Product Recalls
o Outsourced activities
The Importance of Procedures and Work Instructions
Connecting three key elements
Role and Responsibilities Organization’s Management
Review and monitoring
How you can measure the effectiveness of a Quality System?
How to take decisions?
How can you improve a Quality System?