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Responsible Person for GDP

1 Day

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.

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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)
€ 899

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

Your Trainer

Kristina Bindus

  • Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.

  • Co-founder of 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.


Implementation of the New EU GDP Guideline

  • Well-known or new: a summary of the most important changes

GDP Compliance: How to Achieve It?

  • Roadmap: what do I need?

  • How to get started and to maintain a GDP-compliant status?

  • The counterfeit and pharma supply chain

Quality Management System

  • How to develop and implement an effective Quality Management System?

Roles and Responsibilities of the RP

  • Qualification requirements to the RP

  • Duties of the RP

  • How to keep it all under control?

  • What and how to delegate?

  • How to report and control delegated activities?

  • RP deputy: who can help me?

RP Quality Oversight: Principles & Practical Approach

  • RP Quality Oversight: what to oversee and how to proceed?

  • How to establish a Quality Oversight process

Batch Release for Sale: Requirements & Reality

  • Batch release for sale: is this mandatory?

  • Batch release for sale: to do or not to do?

  • What does Final Batch Release mean for RP?

  • RP vs. QP role in Final Batch Release

  • Where your responsibility as RP GDP stops

  • How to identify what to verify and control?

Returns: Time- & Risk–reducing Approach

  • What are the requirements and how to implement?

  • Time- & risk-reducing approach

GDP(/GMP) Inspections

  • GDP inspection readiness

  • Frequent findings

  • Expectations with regards to the RP

Temperature-controlled Distribution

  • Get to know your distribution chain

  • How to identify the weakest links and what to do?

  • How to manage cold chain products: warehousing & transport

  • How to manage 15-25°C products: warehousing & transport

  • Temperature monitoring or control? – what is the best option for the product

How to Manage Outsourced GDP Activities & GDP Audits

  • What is a GDP activity?

  • How to qualify & manage GDP outsourced activities?

  • Approach a GDP Audit

  • Reporting deficiencies : CAPA’s or risk mitigation plan?

  • Quality Agreements requirements & inspectorate expectations

Transport: a Grey-zone or Well-known Activity

  • How to manage GDP-transport?

  • Risk-based approach and where to pay attention to

Management Review & Monitoring in Practice

  • How to identify the parameters for monitoring

  • 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

Contact Quastion for more information about this Responsible Person for GDP training.
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+32 (0) 2 899 05 68

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Leuvensesteenweg 643 bus 7

1930 Zaventem


TAV: BE 0822 940 179

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Qplus consult BV

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