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GMP for MIA HOLDERS

1 Day
GMP

This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and GMP requirements for export and import activities. The aim is to provide you with the tools necessary to help you be GMP compliant, thereby ensuring the quality and integrity of your product. Basic GMP principles, export/import activities, GMP quality system and the batch certification process are highlighted during this course.

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Audience

Anyone directly or remotely interested in Good Manufacturing Practice requirements for export and import activities

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
Price
€ 899

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

Introduction to GMP

  • Production legislation for pharmaceuticals

  • European GMP guidelines and connections

  • Goal and importance of GMP

Base Principles

  • Personnel and outsourcing

  • Facilities and equipment

  • Production, documentation, validation

  • Quality control and self-inspection

  • Complaints and recall

GMP Quality System

  • Quality concepts

  • Install and maintenance of quality systems

  • Applying quality systems

  • GMP quality system components

  • GMP quality system in effect

Export and/or Import Activities

  • Which GMP aspects are concerned?

  • What is applicable to MIA holders?

  • How to comply with GMP requirements for MIA holder?

Batch Certification by MIA Holders

  • Annex 16

  • QP activities and oversight for export-import activities

  • Work organization

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Quastion Learning Center

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

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