Qualified Person (QP) / Responsible Person (RP) Training Program
This training helps you fully understand your legal responsibilities under EU GMP/GDP guidelines, navigate grey areas with confidence, and develop the mindset needed to lead pharmaceutical quality and distribution operations.
Why this training matters
Because the role isn’t just a title — it’s a responsibility. Being a QP or RP means more than signing off on paperwork. You're the final line of defense for patient safety, product quality, and company reputation. And yet, most professionals step into the role with more questions than answers. This training is designed to close that gap.
You'll gain:
Regulatory clarity – Know exactly what the law expects from you (and what it doesn’t).
Decision-making tools – Learn how to assess risk, justify your choices, and sleep at night.
Audit-readiness – Be prepared to speak confidently in front of inspectors.
Professional confidence – Walk away knowing you’ve got the tools to own the role — not just fill it.
Who can attend
This program is ideal for individuals involved in the distribution of pharmaceutical products, including:
Newly appointed Qualified Persons or Responsible Persons
Professionals preparing to step into QP/RP roles
RPs in pharmaceutical distribution, warehousing, or logistics
QPs in manufacturing, import, or release roles
Quality assurance or compliance personnel supporting QPs/RPs
Anyone who wants to understand what it really means to “be responsible”
Course information
Instructor: Nelly Slegers
Duration: One-day intensive training session.
Location: In person
Languages: French - Dutch - English
Certification: Participants will receive a certificate upon successful completion of the test.
Customization: Can be adapted for new RPs, newly promoted QPs, or teams supporting them
Quote on demand
Learning outcomes
Upon completion of this training, participants will be able to: |
Interpret their legal obligations and the limits of their responsibility
Evaluate risk and make compliant, well-documented decisions
Demonstrate proactive oversight in audits and inspections
Communicate effectively across teams to uphold quality culture
Navigate complex scenarios without second-guessing your authority
Syllabus
This course dives deep into the real-world application of QP/RP responsibilities, combining regulation with operational insight. |
1.
Legal Framework & EudraLex Requirements
Role of the QP (Directive 2001/83/EC, Annex 16)
Role of the RP (Directive 2013/C 343/01)
What’s at stake: personal liability, inspection readiness, regulatory expectations
2.
Decision-Making & Risk Ownership
How to make and justify critical decisions (even with incomplete data)
Using risk-based thinking to guide your judgment
Handling “grey zone” situations with confidence
3.
Oversight & Communication
How to monitor compliance without micromanaging
Importance of training and competency in GMP compliance.
Collaborating with supply chain, manufacturing, QA, and external partners
Giving clear, constructive feedback across levels
4.
Documentation & Justification
What you sign… and what you’re truly accountable for
Batch release records, deviation handling
5.
Inspections & Personal Impact
How to prepare for inspections as a QP or RP
Answering tough questions and demonstrating oversight
What to say (and what not to say) when auditors come calling
Meet Nelly, your trainer
This session is delivered by Nelly Slegers, pharmacist and quality expert with 25+ years of hands-on experience in GMP/GDP environments. Nelly brings practical insight, a clear teaching style, and an ability to make regulations feel human — and useful.
Learn smarter. Work clearer. Decide faster. Quality, made human.
Nelly’s approach to real-world quality
At MentorinQ, quality isn’t just a checklist — it’s a living process that drives better understanding, smarter workflows, and faster decision-making.
Our method focuses on three essential actions to make quality practical, human, and sustainable:
Train
Understand the real needs of your team. Create customized training that fits your challenges and turns regulations into practical tools — not obstacles. When people understand why they act, quality becomes a natural part of how they work.
Process
Start from your operational reality — not theoretical models. Together, we build clear, intuitive processes that are tested, flexible, and easy for your teams to apply consistently.
Monitor
Set up simple, effective tracking systems to access the right information at the right time. Make faster decisions, boost your team’s energy, and strengthen compliance — without drowning in bureaucracy.
Ready to make quality click?
Check upcoming training dates
Join one of our next in-person sessions and start turning compliance into confidence.