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Responsible Person/Deputy RP/Advanced GDP Training

 

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 45 years combined experience in the pharmaceutical industry, our trainers who act as RPs will bring a practitioner’s approach to the regulatory requirements of this complex and evolving area in all our training courses. PLS Pharma were the first and are the largest provider of RP and GDP training courses in Ireland. With our partners, RSSL Pharma (servicing the UK & EU markets), we are the premier providers of RP/GDP training and were part of the advisory committee for the RP Gold Training Standard.

  • 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.

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.

Next course: Dublin - 30th & 31st January 2019.

For further information, or to book a place, please contact us or call us on +353 1 20 200 20/+44 203 5822 699. 

Future Courses

  • 2019 schedule to be announced

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

Next course:  Reading (UK) - 23rd & 24th January 2019.

RSSL (Reading, UK) -  Schedule of 2019 RP Courses

  • 13th & 14th March 2019
  • 15th & 16th May 2019
  • 19th & 20th June 2019
  • 24th & 25th September 2019
  • 13th & 14th November 2019

Click here for more details.

View other upcoming courses

Testimonials

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

- Responsible Person (RSSL), 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