SUPPORTING YOUR PROFESSIONAL DEVELOPMENT
When you enrol in a SeerPharma UK Academy course, whether that is a classroom course, a bespoke course or our eLearning, you will be given early access to further resources and a networking group. This group provides compliance support, early access to career opportunities and a chance to influence the industry.
Here’s what you can expect:
SUPPORTING YOUR PROFESSIONAL DEVELOPMENT
When you enrol in a SeerPharma UK Academy course, whether that is a classroom course, a bespoke course or our eLearning, you will be given early access to further resources and a networking group. This group provides compliance support, early access to career opportunities and a chance to influence the industry.
Here’s what you can expect:
An extensive range of resources is made available to all our enrolled students. These are in the form of digital downloadables such as Training Matrices, Risk Assessment Tools and Checklists.
Telephone and email support is provided post course to allow participants to embed their knowledge within their daily routines. We want all our course attendees to have the confidence and skills to put into practice what they’ve learned, and our support extends long after our courses wrap up.
Effective online networks are vital at the best of times, even more so recently. We provide a forum for all our course attendees to ask and answer the sorts of questions only others in the same roles will know. With an audience of like minded professionals, you have the opportunity to influence your industry and get to hear of new career opportunities sometimes before they are made public.
Alongside this content for our enrolled student, we offer free content to our wider network who sign up for our communications.
SeerPharma UK’s Directors have been contributing articles to the UK pharmaceutical sector for many years and alongside their output you will receive professionally curated content from other important sources across the sector.
Here’s a sample of the sort of resources that we share:
MHRA blog posts written by Madeleine Ault
MHRA blog post 15 June 2018
Author: Madeleine Ault
The Responsible Person named on the WDA, p1
EXTRACT: “The licence holder is required to provide an RP with adequate knowledge and experience, learning ‘on the job’ is usual in this industry but experiential training can only provide for some elements of the full package. There is a place for good quality external training and this should be considered by all licence holders.”
“The Cogent recognition process gives you much greater assurance on the standard of external training. The inspectorate wants to see a greater uptake of this and we hope the approval process, and this set of three posts, will contribute to the development and recognition of the RP role across the industry.”
MHRA blog post 13 July 2018
Author: Madeleine Ault
The Responsible Person named on the WDA, p2
EXTRACT: “Experiential learning is commonplace in this industry. There is nothing like trying to conduct a recall and realising it cannot be completed because there are transaction records missing, you don’t have sufficient staff or storage space, or the written procedure cannot be understood. Aside from the obvious point that an effective recall test would have avoided this scenario; the RP at the heart of this will never forget how they learned the essential components of a recall process.”
“People are at the heart of Good Distribution Practice (GDP) and the RP is the central person within a Licence Holder’s operations ensuring compliance with the conditions of the licence and ensuring the quality of the medicinal products handled. All RPs should be aware of, and fulfilling, their responsibilities but they do need the support of the Licence Holder. The Licence Holder has their own responsibilities which many appear unaware of.”
MHRA blog post 8 August 2018
Author: Madeleine Ault
The Responsible Person named on the WDA, p3
EXTRACT: “The contractor should have a thorough understanding of operations before their appointment – ignorance of activity is not a defence and the consequences of non-compliance to a consultant’s reputation can be significant.”
“ … it is not acceptable for the RP to introduce a generic quality system that has not been tailored to the Licence Holder. This is frequently seen by the inspector and can lead to wide-ranging problems with compliance.”
“As the RP, a contractor is in a unique position to ensure that the conditions of a licence are within compliance. This poses a significant challenge to the contract RP and Licence Holder. Ultimately, the responsibility to ensure the quality of medicinal products, and patient safety, fall on their shoulders.”
MHRA blog post 14 July 2016
Author: Steve Todd
Temperature mapping – an introduction
EXTRACT: “Refrigerated medicinal products, part 2: Transportation, packing, temperature management, the use of third party couriers and returns – some things to consider
This is the second of two blog posts dealing with the management of refrigerated medicinal products and like the first, draws on some of the findings from GDP inspections, references to the EU GDP Guidelines 2013, the Green Guide and…”
MHRA blog post 05 May 2016
Author: Steve Todd
Refrigerated medicinal products, part 2:
Transportation, packing, temperature management, the use of third party couriers and returns – some things to consider
EXTRACT: “This is the second of two blog posts dealing with the management of refrigerated medicinal products and like the first, draws on some of the findings from GDP inspections, references to the EU GDP Guidelines 2013, the Green Guide and an article I wrote for the Pharmaceutical Journal a few years ago.
Packing of consignments and temperature management during transportation
Before being transported, refrigerated products should be packed in such a way as to ensure that the required temperatures are maintained throughout the journey and the medicines are transported in accordance with their labelling requirements to prevent jeopardising their quality. Chapter 9.3 of the EU GDP Guidelines mentions this.”