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Self-Inspection Management

1 Day
Auditing

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.

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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 04.jpg

Kristina Bindus

  • 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.

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    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

  • 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 preparation

o code of conduct

o conflict of interests

o questioning techniques

  • Workshop: performance of a self-inspection

Participants about this course:
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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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