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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.
Anyone employed in a GMP environment
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
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.
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
Good Manufacturing Practice Basic or Advanced
Pharmaceutical commercial batches
Bio-Pharmaceutical commercial batches
Good Manufacturing Practice for API’s for Commercials or IMP Batches
Good Documentation Practice in GMP
Training on One of the GMP Chapters/Annexes on Request
Quality and Technical Agreements