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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 Training 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.

UPCOMING COURSES FOR 2021

Next Date Still To Be Confirmed 2021

Click here to register your interest and receive booking guidelines - places on this course are booking up very fast.

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

Testimonials

"The course was very well organised and planned. Was not sure of Zoom but it was very well organised and I feel I can now do Zoom calls easily."

"The worked examples/group sessions were great. Having the groups post their answers/sending to other teams was fantastic."

"I meet plenty of professionals on my travels so I'm certainly happy to recommend PLS Pharma when the opportunities arise."

"All of the reading material provides a great knowledge bank to have."

"Excellent, everything was very efficiently run."

"Breakout Groups with activities to undertake helped to gain valuable understanding of personal experiences. Gained lots of new knowledge and deep understanding of various topics."

"Overall I found the course extremely useful and beneficial and the notes provided were important to our continual learning throughout."

"I was very impressed with the course. Not easy to change from classroom to online and still deliver the course you did. Well done, really enjoyed the course."

"It was good - the breakout rooms broke up the course. It was very interactive and I enjoyed the input of everyone."

"Real-life examples/cases that were used throughout the course to highlight certain points from GDP guidelines. Really illustrated the reason why GDP guidelines were so badly needed in the industry."

"It was just long enough to cover all the material comfortably. Notwithstanding the pandemic, course was great and participation from attendees was also motivating."

VIRTUAL Responsible Person - February 2021

"There is no question that the team have a wealth of experience and the course content was comprehensive;  I believe it gives a sound foundation for the RP, with the understanding that they must supplement with ongoing learning."

"I found all topics useful. Even areas where I had strong knowledge, I still picked up tips from others."

"The breakout rooms worked really well, the course reading material was provided in a way to break it down into smaller chunks and kept the course flowing well between presenters."

"I thought the length/format/running order went really well. Typically two full days in a row can be quite tiring, but I found myself engaged throughout."

"Just thank you for putting on such a great course. It was really well rounded and covered so many topics in the two days. I'm really hoping the RP forum goes ahead this year either in person or virtually!"

"All in all a really excellent course with excellent facilitators and administrators. Very valuable to me and anyone who attends. I would strongly recommend to others."

VIRTUAL Responsible Person - January 2021

"Considering these challenging times and the necessary change in training environment from face to face to online via Zoom, I still considered this course (and self paced pre-courses) to have exceeded my expectations. The course exercises and breakout sessions and open discussions ensured a high level of engagement throughout."

"Thanks to everyone at PLS Pharma for the coordination activities and for presenting such an enjoyable course. I’ve learned so much in two days and I’m excited to start on my journey to become a DRP and eventually an RP."

-VIRTUAL Responsible Person, Oct 2020

"I think anyone working in quality should complete this course as it gives you a great understanding of the role of an RP and also the quality function within a company."

"I found the two online training courses very informative beforehand. Their design is excellent as it ensures participants stay engaged throughout due to the constant questions."

"Great course, well done. Most interactive and engaging course I have completed virtually."

-VIRTUAL Responsible Person, Oct 2020

"Course content was extremely useful. I found the course much more advanced and professional in comparison to the other GDP course that I have completed, performed by different vendor. From my perspective, I would highly recommend this course to any RPs and deputy RPs."

- VIRTUAL Responsible Person, Oct 2020

“Outstanding – from the minute I signed up I had more than enough information of what was expected of me as an attendee, how the course would run and also each query I had prior to completing the course was answered promptly.”

- VIRTUAL Responsible Person, 2020

 “overall content of the GDP training was very useful in understanding the role of RP, DRP and impact of GDP practices on product quality”

“Very efficient, proactive and friendly approach” “Excellent and Well Organised from start to the finish”

-VIRTUAL Responsible Person, 2020

 “The breakout rooms were very useful they get you thinking about real world problems and the other course members add a perspective you may not have considered before.”

-VIRTUAL Responsible Person, 2020

 “I really enjoyed it”

“…very up to date, relevant and included all recent news”

-VIRTUAL Responsible Person, 2020

 “…great tutors, very knowledgeable and experienced. Great bunch of trainees, great tutors, I really enjoyed the course – Thank you.”

- VIRTUAL Responsible Person, 2020

"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