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This interactive course with workshops is designed to provide you with sufficient background on legislation applicable to Self-inspections. The course aims to enable you to set-up and implement an efficient process that fits your organization. You will learn how to perform self-inspections and how your organization can benefit from it.
Audience
Functions involved in set-up and performance of self-inspections, responsible for process improvement and responsible for the Quality System
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
Price
€ 799
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
Why Self-inspections are needed
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GxP: relevant regulation about self-inspection in GMP and GDP
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The purpose of self-inspections
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Self-inspection - internal audit - external audit: what's the difference?
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Expectations of inspectorate
How your Organization can benefit from Self-inspection
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The main advantages of self-inspection
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CAPA and improvements
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Follow-up and effectiveness check
How to set-up a Process that fits your Organization
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How to start and what elements you need
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How to develop a process
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How to choose an auditor, tasks and responsibilities
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Report writing and results reporting
Self-inspection Program Set-up and Implementation
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Workshop: set-up a self-inspection program
Performance of Self-inspection
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How to perform a self-inspection:
o preparation
o code of conduct
o conflict of interests
o questioning techniques
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Workshop: performance of a self-inspection
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Self-Inspection Management
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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