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+25 years of experience

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

985 € excl VAT/person

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 under EU GMP (Directive 2001/83/EC, Annex 16)

Role of the RP under EU GDP (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, and audit trails

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.

Book a discovery meeting

Let’s talk about what your team needs and how I can help — no pressure, just clarity.