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To be Audited and Inspected

1 Day
Auditing

This interactive course with workshops is designed to provide you with the guidance and tools to always be prepared for Audits and Inspection.

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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
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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

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

  • Conclusions

Participants about this course:
Date

Date 1

Date 2

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Contact Quastion for more information about this To be Audited and Inspected training.
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Other courses you might be interested in:

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Auditing Principles

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Lead Auditor

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On demand

Self-Inspection Management

1 Day

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To be Audited and Inspected

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Quastion Learning Center

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

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