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A new role was announced at the MHRA GDP Symposia in London, yesterday. Cheryl Blake’s presentation “Preparing for a Changing World” included information and potential scenarios post Brexit. Within this presentation was information on the new role… the “RPI” The RPI (Responsible Person – Import) will come into being in the coming weeks and months,…

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The Legal supply Chain – How can we protect it? By increasing the number of referrals to the MHRA   Sadly, many wholesalers are scared of the regulator, but it should be noted that there is a legal requirement under section 43 of the Human Medicines Regulations for the licence holder to advise the competent…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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  GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We aim to provide as much value to you and your company…

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  In November 2017, the MHRA released a document that contained deficiency data from inspections carried out in 2016. It included the most common areas of deficiencies found during inspections in relation to the GDP EU Guidance 2013/C 343/01, as well as examples of deficiencies from each chapter.  The data showed that the top deficiency areas…

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Since the approval for specialist prescribers to write scripts for CBPMs (Cannabis based medicinal products) was given for 01 Nov 2019, there has been a flurry of activity to get licensed. Paradigm Shift have had multiple enquiries about licensing for the procurement and supply of CBPMs, and are working with a number of companies in…

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The mention of the IAG can strike fear into the hearts of many wholesalers… usually those who are not compliant with GDP. So, who are the IAG? The letters IAG stand for “Inspection Action Group” and they’re a multidisciplinary team that are part of the MHRA. IAG 1, responsible for GDP, GMP and blood banks meets…

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Starting in February (2019) we are extending the duration of our training courses so that they will now run for two days instead of one. Day One will be an intensive session that covers all chapters of the EU Guidance, expectations of the MHRA, bona fides, deviations, CAPA, Change Control and Complaints. This is an…

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Holders of a Wholesale Distribution Authorisation (Wholesale Dealer Authorisation) can be suspended for a number of reasons, but most commonly to regulatory action from the MHRA (Medicines and Healthcare products Regulatory Agency). Paradigm Shift Consulting have worked with many customers who have experienced MHRA regulatory action resulting in suspension of the licence and being listed on the public MHRA Suspended…

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  GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We aim to provide as much value to you and your…

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  GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and…

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  GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We aim to provide as much value to you and your…

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  GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and…

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  GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and…

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  GDP Training for RPs and Managers Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and…

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  GDP Training for RPs and Managers   Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We aim to provide as much value to you and…

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As a senior manger, Licence Holder or Responsible Person (RP) what training have you had, what do you offer your teams, and do you take regular update/refresher training to evidence your continual professional development? GDP training is a requirement for all staff members in GxP require to maintain and develop knowledge and to work towards compliance,…

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GDP Training for RPs and Managers   Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We aim to provide as much value to you and your…

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 GDP Training for RPs and Managers   Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We aim to provide as much value to you and your…

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GDP Training- Self-Inspection & Auditing   Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We aim to provide as much value to you and your company…

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GDP Responsible Person and Management Training   Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA and Deviations We aim to provide as much value to you and your company as possible…

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GDP Responsible Person and Management Training Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Training- Risk Management   Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01. This session focuses on Risk Management. We aim to provide as much value to you and your company as possible that’s why…

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GDP – Self Inspection and Auditing Training Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We aim to provide as much value to you and your…

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GDP Responsible Person and Management Training    Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We aim to provide as much value to you and your…

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GDP – Self Inspection and Auditing Training    Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We aim to provide as much value to you and…

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GDP Training – Risk Management     Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and your…

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GDP Responsible Person and Management Training    Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and…

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GDP Training on Change Control, CAPA, Deviations and Falsified Medicines Awareness    Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as…

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GDP Training – Self-Inspection and Auditing    Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more.   We aim to provide as much value to you and…

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  Quality Risk Management (QRM) should be focused on the quality of the product – the level of detail corresponds with the task in hand. It is a  systematic approach for assessment, control, communication and review of the risks to the quality of the medicinal product is needed. Managing Risks There are often issues, and…

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Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. For more information on all of our courses or a pre-book one of our sessions, please call 0330…

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Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01. This training session covers Self-Inspection and Auditing. Please follow and like us:

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Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01. This training session covers Risk Management. Please follow and like us:

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We alternate GDP training for RPs and Managers, with audit training and more focussed training on CAPA, changes, deviations, falsified medicines, returns and complaints. These are intensive courses, from 9am til 5.30pm, requiring your full attention, so we recommend you stay locally for the night before if you are more than an hour away. In…

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