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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.
Audience
Anyone interested in the requirements regarding Audits and Inspections
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
Price
€ 497
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
To be Audited and Inspected
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What is an audit / inspection?
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What is the audit objective?
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What is the inspection objective?
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List of Main Pharmaceutical Regulatory References
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Audit / Inspection Main steps
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Audit / Inspection Approach
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Whose Audit / Inspection is this?
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How to prepare the Audit / Inspection?
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What happens during an Audit / Inspection?
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Support during the Inspection
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Code of conduct
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Conclusions
Participants about this course:
Date
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To be Audited and Inspected
date
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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