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
Kristina Bindus
-
Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.
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Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.
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Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.
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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.
- 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
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Production legislation for pharmaceuticals
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European GMP guidelines and connections
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Goal and importance of GMP
Basic Principles
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Personnel and outsourcing
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Facilities and equipment
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Production, documentation, validation
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Quality control and self-inspection
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Complaints and recall
GMP Quality System
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Quality concepts
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Install and maintenance of quality systems
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Applying quality systems
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GMP quality system components
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GMP quality system in effect
Good Manufacturing Practice Basic or Advanced
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Pharmaceutical commercial batches
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Bio-Pharmaceutical commercial batches
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IMP’s
Good Manufacturing Practice for API’s for Commercials or IMP Batches
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Pharmaceuticals
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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
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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