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Responsible Person/Deputy RP/Advanced GDP Training

NOW OFFERED AS Interactive Tutor-led Online Virtual Classroom Training Courses

The EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use, 2013/C 343/01, state that:

“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.”

With over 150 years combined experience in the pharmaceutical industry, our trainers and consultants - the majority of whom act as RP/DRP's (Deputy RP) on licences themselves - bringing practitioner’s approach to the regulatory requirements of this complex and evolving regulatory environment.

PLS Pharma are the largest provider of RP and GDP training courses in Ireland.

We have carried out training for management, staff and outsourced providers from over 45 countries over the last 15 years and the feedback we have received from delegates has been exceptional.

We have had the pleasure of delivering GDP and RP Training on behalf of RSSL Pharma from 2007 to 2019. 

PLS Pharma delivered the first GDP course in Ireland in November 2005. Today we still work with 90% of the same customers who joined us on our pioneering GDP Journey. We commenced GDP training in the UK following the success of the Irish GDP Training Course. This course was fine tuned and delivered to a new UK audience starting in early 2007 in RSSL Pharma in Reading. We believe this GDP course was one, if not the actual, first GDP course held in the UK.

We commenced RP Training in 2007 in Ireland and from that first course, we tailor-made a UK version and started to deliver these courses for RSSL Pharma for RP's shortly thereafter.

Ciarán, our Founder, is the largest trainer of RP's in UK and Ireland. 

 

  • Is your Responsible Person (RP) properly trained?
  • Can your Deputy RP deputise effectively for the RP, including managing inspections? (See excerpt below from HPRA Newsletter, Issue 59 - April 2018)
  • Can your RP/Deputy RP successfully manage a product recall?
  • Are you fully operating within compliance with all Directives, Regulations and Guidelines?
  • Are you complying with the legal requirements of your licence?
  • Have you full traceability in place and are returns managed within compliance?
  • Have you carried out risk assessment in your supply chain?
  • What are the current roles and responsibilities for an RP/Deputy RP?

HPRA Newsletter Issue 59, Pg 4:  Notification of GDP inspections: ...  "It is expected that a deputy responsible person has adequate knowledge and oversight of the systems in place such that they can effectively deputise for the responsible person.  This includes management of inspections. The HPRA reserves the right to perform unannounced inspections."

We can train your RP, Deputy RP and other staff to confidently comply with all legal requirements. We have delivered public and tailor-made, in-house Responsible Person/Deputy RP/Advanced GDP Training courses to staff from over 40 countries worldwide. Contact us now!

Participants will learn about the impact of the current EU GDP Guidelines 2013/C 343/01, and the implications for RPs and management. The impact of the new Falsified Medicines Directive will also be explored.

All our RP Training courses meet the EU GDP requirements for an RP operating on a licence across EU countries and complies with the RP Gold Standard. We also specifically examine HPRA and MHRA requirements, as both regulatory bodies are highly regarded at EU and global levels.

Future Courses

RP/DRP/Advanced GDP Interactive Tutor-led Online Virtual Classroom Training Course: 25th and 26th August 2020

Click here to register your interest and receive booking guidelines.

A Certificate of attendance including CPD hours will be issued to all who complete the course and once full payment is received.

Testimonials

"Trainer (Ciarán) had very good knowledge and experience of having worked in the industry and provided numerous eye openers"

- Responsible Person, 2018

 "If only all courses were like this!  You go away feeling very educated and really understanding what you have learnt"

- Responsible Person, 2018

"Ciarán’s approach to training was amazing, very engaging.”

- Responsible Person, 2018

“Excellent course – to the point and covered a wide range of topics all relating to the role of an RP”

- Responsible Person, 2018

“In depth explanation of EU Guidelines and application in real life”

– Responsible Person, 2017

“Excellent, insightful course which will be hugely beneficial personally and for the wider organisation to obtain GDP certification.”

– Responsible Person, 2017

“I thoroughly enjoyed the course and I feel much more confident about GDP and the impact it has on patient safety.  I found serialisation most useful as I will have to include this in many of my TA updates”

– Responsible Person, 2017

“Exceeded expectations in terms of relevance, particularly guidelines around responsibilities. ” 

– Responsible Person, 2016

“The course outlined very clearly my responsibilities as the new RP!” 

– Responsible Person, 2016