Register a second person and receive 5% off of your total course-fee immediately!
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.
Functions involved in set-up and performance of self-inspections, responsible for process improvement and responsible for the 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.
Why Self-inspections are needed
GxP: relevant regulation about self-inspection in GMP and GDP
The purpose of self-inspections
Self-inspection - internal audit - external audit: what's the difference?
Expectations of inspectorate
How your Organization can benefit from Self-inspection
The main advantages of self-inspection
CAPA and improvements
Follow-up and effectiveness check
How to set-up a Process that fits your Organization
How to start and what elements you need
How to develop a process
How to choose an auditor, tasks and responsibilities
Report writing and results reporting
Self-inspection Program Set-up and Implementation
Workshop: set-up a self-inspection program
Performance of Self-inspection
How to perform a self-inspection:
o code of conduct
o conflict of interests
o questioning techniques
Workshop: performance of a self-inspection