Responsible Person Refresher!

Everything you need to know to maintain your status.

 

“I need to do some RP refresher training. Do I have to attend the Gold Standard Course every year or do you provide a summarised course option?”

This is a typical query we receive from people acting as the Responsible Person. To clarify, there is no requirement in the guidelines or regulations for a Responsible Person to undergo a Cogent Approved Gold Standard Course on an annual basis as an RP Refresher.

Remember that not all training providers have their RP course mapped to the Cogent Gold Standard, despite what they say. Ask for the certificate and check the course is approved, not just an assured provider.

So what is RP refresher training?

RP refresher training is personal to you and your ongoing learning and development. There is no ‘one-size fits all’ training.

Some examples include:
  • Training in a specific part of the quality management system identified as a learning requirement.
  • Attending training symposiums or area-specific courses.
  • Self-learning activities related to keeping up to date with regulatory and industry changes.
  • Networking with peers and documenting learning points, sharing ideas and insight for best GDP practices.
  • Completing a Continuous Improvement project.

Why do you need to do it?

Under GDP Chapter 2, subsection 4, it states that:
“All personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks. Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme. The responsible person should also maintain their competence in GDP through regular training.”

It is required that the Responsible Person maintains a training record in which they can demonstrate their ongoing training and learning. Remember, “regular training” does not mean repeating the same training every year, it’s about expanding and building on the current knowledge and experience you already have.

How can we help you?

At SeerPharmaUK, we offer a whole range of different and bespoke courses that can help you and your team. With training and assistance from former MHRA GDP Inspectors, it gives you plenty of scope to learn from others in the industry but also to ask questions regarding regulatory challenges in a safe and confidential environment. Why not have a look at the RP Refresher course (project based) and pick a project that exactly meets your learning and development needs?

So, what are you waiting for? Take a look at our course dates to get started!

Article Library

Nuala Calnan PhD biography

Nuala is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and includes research for FDA(USA) and HPRA(Ireland) on risk surveillance, patient safety and product quality in themanufacture and distribution of drugs.

Nuala works with organizations on transforming organizational culture, delivering more effective end-to-endproactive risk management, implementing knowledge excellence strategies, behavior-based qualityexcellence and enhancing performance management through people. She is the founder of the Quality Risk

Management Institute and is currently the Co-Ordinator for the Operational Excellence Team at the Institute of Production & Supply Chain Management at St. Gallen University.

Nuala co-leads the ISPE Cultural Excellence Team, acted as Technical Author on the AdvancingPharmaceutical Quality (APQ) Guide series. At TU Dublin, Ireland, Nuala leads a number of patient focusedregulatory science research projects at Masters and PhD level and teaches on the Executive MBA (LifeSciences) on OPEX, QRM and Regulatory Science.

Professor Amira Guirguis biography

Professor Amira Guirguis is the Chief Scientist at the Royal College of Pharmacy and Professor of Pharmacy at Swansea University. A pharmacist independent prescriber, researcher and scientific leader, she works at the interface of pharmacy practice, medicines safety, research, regulation and public policy.

She is internationally recognised for her work in substance misuse, novel and emerging drugs, pharmacovigilance, harm reduction and pharmaceutical science, and has authored more than 100 scientific publications.

Amira has also pioneered the UK’s first Home Office-licensed pharmacist-led drug-checking service.

Alongside her RCPharm leadership role, Amira serves on the UK Government’s Advisory Council on the Misuse of Drugs, the General Pharmaceutical Council’s Fitness to Practise Committee, and the Pharmaceutical Society of Ireland’s Accreditation Panel.

As Chief Scientist, she leads RCPharm’s work to strengthen science and research across the profession and ensure robust evidence informs pharmacy practice, policy and innovation. Her current interests include pharmacovigilance, netnography, diversion of pharmaceuticals, and the opportunities and emerging risks associated with rapidly evolving medicines and therapeutic technologies.

Carolina Luna biography

Carolina Luna is Quality Manager and Responsible Person UK & NL at AIT Worldwide Logistics. With a career spanning pharmaceutical logistics, manufacturing and food production, she brings broad experience of applying GMP and GDP principles across regulated environments. Carolina holds a bachelor’s degree in Agro-Industrial Engineering, specialising in Food Processing.

Throughout her career, Carolina has focused on turning regulatory requirements into quality systems that work in practice. Her achievements include integrating three separate quality management systems into one, leading applications for WDA, API and MIA licences, and transitioning a paper-based QMS to an electronic platform. She has also supported regulatory inspections, conducted supplier audits, developed quality KPIs and delivered GMP/GDP training.

Carolina is currently completing a Level 4 AI and Automation Practitioner qualification and exploring practical applications of AI within pharmaceutical quality management. Through her presentation, “Practical AI for Quality and Compliance”, she aims to give quality professionals the confidence to use AI in a practical and controlled way, while reinforcing that technology should support, rather than replace, professional judgement and human oversight.

Harry Hughes biography

Harry Hughes is UK Ambassador for TAPA EMEA and Managing Director of FET Logistics Ltd. He has nearly 30 years’ experience in logistics and supply chains, specialising in secure, GDP-compliant pharmaceutical transport. His work spans quality systems, cargo crime prevention and supply chain resilience.

Stuart Tatters biography

With over 20 years in logistics, freight forwarding, and time-critical supply chains, Stuart Tatters has learned firsthand how crucial it is to know where your assets are, and where they’re going, at any given moment. In fast-moving, high-stakes environments, visibility isn’t a luxury, it’s a necessity.

That experience shapes everything he does at Sensos, where he helps organisations turn complex supply chains into responsive, efficient ecosystems through end-to-end visibility, AI-powered analytics, and smarter execution. His approach comes down to aligning people, technology, and systems; because when those three work together, you get more than a functional supply chain, you get a competitive advantage.

 

Titus Rawlins bography

A former Royal Navy Ship’s Navigator and Diver, Titus is an airline pilot of 25 years’ experience and a Human Factors Instructor who specialises in training teams who need to perform in hazardous work environments. He is qualified to deliver regulatory training to Flight Crews by the European Union Aviation Safety Administration and both the UK’s Military and Civil Aviation Authorities. 

Presenting to high performance groups and industries as diverse as Medicine and Logistics, from the UK, Europe and as far afield as Qatar and Nigeria, Titus employs a dynamic and interactive style to deliver easily relatable training models and case examples. His sessions have been proven to enhance communication and decision making, thereby minimising risk while improving efficiency, effectiveness and safety. 

Mikael Ginai biography

Mikael Ginai is Sales Director at Ginai Pharmaceuticals, helping drive a new generation of pharmaceutical wholesale.

Combining commercial leadership with a passion for technology and innovation, he has helped lead the development of Ginai’s own in-house ERP system and introduced smarter, more efficient ways of working.

His focus is on building upon the strong foundations of the pharmaceutical industry while embracing technology, innovation and new ideas to help shape its future.