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This interactive course with workshops is designed to provide you with the guidance and tools to always be prepared for Audits and Inspection.
Anyone interested in the requirements regarding Audits and Inspections
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.
To be Audited and Inspected
What is an audit / inspection?
What is the audit objective?
What is the inspection objective?
List of Main Pharmaceutical Regulatory References
Audit / Inspection Main steps
Audit / Inspection Approach
Whose Audit / Inspection is this?
How to prepare the Audit / Inspection?
What happens during an Audit / Inspection?
Support during the Inspection
Code of conduct