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This training is a supplement to our successful RP for GDP course. Learn GDP news and importance of risk management within a GDP quality system. Learn more on management of distribution and transport.
Audience
Anyone who followed a RP training in the past and needs to update his or her knowledge
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
Price
€ 899
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
Management of Authorized Activities
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Which activities (purchase, storage, supply, export)
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Type of products (cold chain, psychotropics, ...)
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Supply chain of products (physical + financial flow): from manufacturer to customer
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Samples
Quality Management System
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Activities, processes, responsibilities
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Structure
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GDP risk assessment
Complaint Handling
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Quality vs distribution
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RP oversight
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Timelines + link with recall and PV
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Interaction with supplier, warehouse, transporter
Returns
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Risk based approach
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Visual check
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Document check
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Declaration storage conditions
Participants about this course:
Date
22 November 2021
Date 2
Date 3
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Responsible Person for GDP: Refresher
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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