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This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and GDP & GMP requirements for outsourced activities. The course is specific for who is in start-up step to set-up a process on subcontractors management. Learn how to approach this complex topic and to secure your business. Participants receive an introduction and learn about the general principles that will help them in the development of a process on subcontractors.
Audience
Anyone interested in setting-up, simplify or improve a process on subcontractors management
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
Price
€ 699
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
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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.
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She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.
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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
Which Activities can you outsource
Learn how to review & monitor your Subcontractors
When do you need a Quality/Technical Agreement
Audit or Questionnaire
Expectations of the Inspectorates
Workshop
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design a step-plan for process ‘qualification of a warehouse’
Participants about this course:
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Outsourced Activities Management
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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