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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)
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 Bindus

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:
Date

12 March 2020

Not available on this date?
You can always contact us for a course on demand
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+32 (0) 2 899 05 68

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Leuvensesteenweg 643 bus 7

1930 Zaventem

Belgium

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a division of

Qplus consult BVBA