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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.
Anyone directly or remotely interested in Good Manufacturing Practice requirements for export and import activities
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
per participant (excl. VAT)
✓ Exclusive learning approach
✓ Personal course documentation
✓ Lunch, water, coffee & tea
✓ Course certificate after completion
Quastion Learning Center (Qplus consult BVBA)
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
Introduction to GMP
Production legislation for pharmaceuticals
European GMP guidelines and connections
Goal and importance of GMP
Personnel and outsourcing
Facilities and equipment
Production, documentation, validation
Quality control and self-inspection
Complaints and recall
GMP Quality System
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
QP activities and oversight for export-import activities