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Good Manufacturing Practice: Refresher Course

1 Day
GMP

This interactive course is intended for people that are employed in a GMP environment and aims to refresh the knowledge of the participants on this subject.

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Audience

Anyone employed in a GMP environment

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
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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

Basic 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

Good Manufacturing Practice Basic or Advanced

  • Pharmaceutical commercial batches 

  • Bio-Pharmaceutical commercial batches 

  • IMP’s

Good Manufacturing Practice for API’s for Commercials or IMP Batches

  • Pharmaceuticals

  • Bio-pharmaceuticals

Good Documentation Practice in GMP

Training on One of the GMP Chapters/Annexes on Request

Contract Manufacturing

Quality and Technical Agreements

Self-inspection

Participants about this course:
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Good Manufacturing Practice: Refresher Course

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Quastion Learning Center

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

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