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This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and GDP requirements. You will learn about the role of the Responsible Person and his/her responsibilities according to GDP requirements.
Audience
Anyone who is becoming or is in function as RP, Deputy or QP, or is involved in QA/RA. Anyone interested in Good Distribution Practice requirements
Time Schedule
07:30 - 08:00
Registration & coffee
08:00 - 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
Implementation of the New EU GDP Guideline
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Well-known or new: a summary of the most important changes
GDP Compliance: How to Achieve It?
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Roadmap: what do I need?
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How to get started and to maintain a GDP-compliant status?
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The counterfeit and pharma supply chain
Quality Management System
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How to develop and implement an effective Quality Management System?
Roles and Responsibilities of the RP
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Qualification requirements to the RP
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Duties of the RP
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How to keep it all under control?
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What and how to delegate?
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How to report and control delegated activities?
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RP deputy: who can help me?
RP Quality Oversight: Principles & Practical Approach
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RP Quality Oversight: what to oversee and how to proceed?
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How to establish a Quality Oversight process
Batch Release for Sale: Requirements & Reality
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Batch release for sale: is this mandatory?
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Batch release for sale: to do or not to do?
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What does Final Batch Release mean for RP?
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RP vs. QP role in Final Batch Release
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Where your responsibility as RP GDP stops
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How to identify what to verify and control?
Returns: Time- & Risk–reducing Approach
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What are the requirements and how to implement?
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Time- & risk-reducing approach
GDP(/GMP) Inspections
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GDP inspection readiness
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Frequent findings
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Expectations with regards to the RP
Temperature-controlled Distribution
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Get to know your distribution chain
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How to identify the weakest links and what to do?
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How to manage cold chain products: warehousing & transport
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How to manage 15-25°C products: warehousing & transport
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Temperature monitoring or control? – what is the best option for the product
How to Manage Outsourced GDP Activities & GDP Audits
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What is a GDP activity?
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How to qualify & manage GDP outsourced activities?
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Approach a GDP Audit
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Reporting deficiencies : CAPA’s or risk mitigation plan?
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Quality Agreements requirements & inspectorate expectations
Transport: a Grey-zone or Well-known Activity
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How to manage GDP-transport?
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Risk-based approach and where to pay attention to
Management Review & Monitoring in Practice
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How to identify the parameters for monitoring
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The Best Industry Practices for Management Review and Monitoring
Participants about this course:
"This RP GDP training met my professional education needs."
Karlien Velghe
"This course was well-organized and easy to follow."
Regulatory Affairs & Pharmacovigilance Manager at Daiichi Sankyo Belgium
"Participation and interaction during this course were strongly encouraged."
Medical Team Leader at a consultancy company
"The topics discussed during this course were relevant for me. The educational materials distributed were helpful."
Jo-An Rigo, Regulatory Affairs Officer at Menarini Belgium
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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