Paradigm Shift Consulting

04/04/2024

🎟 Secure your tickets NOW! Join us for the UK GDP Association C.I.C (Community Interest Company) inaugural conference on May 15th & 16th, 2024 in Northampton, in person or online!

Join like-minded individuals for this groundbreaking operations-focussed high value event, where industry luminaries, outsourced powerhouses, and workshop wizards converge to empower your regulatory journey! 😁 🌐💼

This high value CPD event is suitable for all involved in Good Distribution Practice activities, from QA, Operations, Warehouse and Senior Management, we have you covered.

Speakers include Cheryl Blake, Lead Senior GDP Inspector, Mr Alan Bentley ex-Lead Senior GDP Inspector and GDP Consultant, Jenna Cordery Logistics and Export Specialist, Dominic Parry of Inspired Pharma the UK's leader in PQMS Lead Auditor Training, and many more.

https://ukgdpassociation.org.uk/events/

Register and become members to save on ticket prices.

The UK GDP Association C.I.C is happy to announce that our first Annual Conference will be held on Wednesday 15 May 2024 and Thursday 16 May 2024, in

15/12/2023

Are you ready for a quality deal? This Christmas.. we are offering you a 30% off discount on all our online GDP Training courses. Whether you need GDP refresher training or are to new the industry, we have the right training solution for you.

This offer is valid only until December 31st, so hurry and contact us today or visit gdptraining.co.uk and use discount code "XMAS23" for 30% off. Quality management is not a cost, it’s an investment. And this Christmas, you can invest in quality for less.

https://gdptraining.co.uk/

29/06/2023

It’s been one thing after another…

The pandemic years were difficult and fraught; the first of its kind sweeping the UK on a scale not seen since 1918, and it is still reverberating in our society. And now there’s another crisis in Europe which is a challenge on many fronts, not least in medical and patient care costs. The repercussions may be felt for quite a long time…

Paradigm Shift Consulting Limited has been in the mix throughout, establishing strong foundations while modifying our services and support functions onto the web, to accommodate the restrictions, and (where possible) the budgets of the clients seeking our assistance. We weathered this storm and have supported many others along the way, only because of the strong foundations we have established, and we continue to do so.

Having strong foundations has enabled us to come through the difficulties with continued strength and confidence. We continue to receive written plaudits and comments from clients who have benefited from our services. Visit the link below for a selection of them, and a personal message from our founder and CEO, Dave Rushton.

https://paradigmshiftconsulting.co.uk/strong-foundations/

29/06/2023

Keeping licensed premises clean and hygienic to a standard that meets GDP compliance, is an ongoing task: It is not an operation that should be engaged lightly!

Dust is highly penetrative, if left to accumulate for too long. And of course, people need to eat and drink. The only way to deal with the ingress of dirt, water, salt and debris correctly and efficiently, is to establish a clear and systematic Warehouse Cleaning procedure with your cleaning team, whether they are dedicated full time, or allocated members of your staff, operating on a rota system.

As always, the quality of the product and patient safety are the primary considerations in Warehouse Cleaning. Paradigm Shift Consulting have launched a Warehouse Cleaning and Personnel course, to help you undertake the task in a way that meets GDP Compliance, and is supportive of the Quality Management System.

To read this article in full, go to: https://gdptraining.co.uk/warehouse-cleaning-and-personnel/

06/04/2023

Our popular GDP Awareness Training course for 2023 has been revamped, and is now more interactive, accounts for recent regulatory adjustments post-brexit, and is also now CPD accredited! Call us to keep your staff and yourself bang up to date in compliance. Discounts offered for group bookings...

06/04/2023

We have been hard at work reviewing details since Brexit, and recent regulatory adjustments are now accommodated. We have new courses, including Medical Devices Training, Driver Training, Pest Control, Thermo Compliance in Warehouses.

05/04/2023

Buying a Lloyd's Pharmacy? Great prices abound, and we are very happy for you!

Do you want to get a WDA to continue supplies to the contracts at that site?

DON'T DO IT! (in the vast majority of cases…)

We have had quite a few calls over the last few weeks and we can tell you now, it is NOT easy.
It is NOT a money spinner and it may take up to 4.5 months for a WDA and 9 months for a CD licence, what with MHRA and Home Office delays.

Why are we turning down work? Because it isn't good work, and not all money is good money.

Holding and running a WDA the "right" way is not easy, not cheap, and not something you can just bolt onto your pharmacy. To do it right costs, and in most cases there are no returns on investment, which to Paradigm Shift Consulting Limited is bad business.

"Just take their money" used to be something we heard an awful lot, but we do not want to create problems for our clients, the supply chain, us or the MHRA, by getting licences for people who do not understand, or will not appropriately resource.

It will pain you to "lose" business, but there are other simpler options such as broker registration, or signing up as a commission based business development consultant, negotiating on behalf of the supplier, obviating the need for a broker reg completely.

So why do we offer you services where we get no financial benefit? Because it's the right thing to do, and it is what we would choose ourselves.

Good consultants solve problems, not prolong them for financial benefit.

We have a number of companies we work with that will be happy to discuss your needs. In most cases, your work will be supply against prescription, so getting a WDA and CD licence for requisitions is quite frankly, bonkers.

Heed our words... don't do it. And if anyone is entertaining you on this, question in whose best interests are they actually working for.

23/03/2023

GDP Awareness Training 2023
Our industry leading and popular GDP Awareness course is designed to give your team a great overview of the core elements of GDP.

All staff MUST be trained in GDP ahead of carrying out their activities, and must be deemed competent, and it can be challenging to have new starters trained in good time.

Our course covers such important topics as the QMS, documentation, opportunities for improvement, complaints, falsified medicines and the concepts of deviation, CAPA and Change Control.

You'll learn about the core requirements of GDP Guidelines 2013/C 343/01 that relate to all personnel in your team and how to implement and maintain quality and compliance within your company.

And the best part? Our course is perfect for commercial, customer service, warehouse teams and cleaners alike.
It's a convenient and cost-effective way to stay up-to-date with your yearly training requirements, and you can learn at your own pace without the stress and expense of traditional training methods.

Our learning objectives are clear: to help you understand the importance and requirements of GDP, recognise your role in implementing and maintaining compliance, and understand the role of the Responsible Person and Quality Management System.

Our course is designed to be interactive and engaging. Your teams should see an immediate improvement in their knowledge and understanding of GDP, as well as feel more confident in their role within the industry and your business.

Learn what GDP is and how it impacts you by signing up for our great value online course.
We update this course annually and even better it is CPD accredited!

Large volumes of personnel? We can “do a deal” and if you subscribe to annual refreshers we can offer you a better rate too!

This course is an excellent “all-rounder” and can be combined with our deeper learnings, including GDP and thermal compliance for warehouse people, QA courses, cleaning courses and more, to build an almost bespoke training package for your teams.

Paradigm Shift Consulting

22/03/2023

Struggling to keep up, or lost in the maze of GDP regulations?
Do you want to check your business is compliant in Good Distribution Practice?

Licence Holder or Senior Management and unsure of what your RP is expected to do?

Look no further than Paradigm's Cogent Assured One day intensive online training webinar!

Our monthly webinar cover all working chapters from the GDP Guidelines, the Human Medicines Regulations 2012, and MHRA expectations giving you a comprehensive understanding of the regulations with an operational focus.

We take the regulations a step further by providing real-life examples and scenarios, so you can apply your knowledge in a practical way.
And here's the best part: our webinars include online assessments, so you can take your assessments in your own time and pace. You'll come away with a tangible understanding of GDP that you can apply to your work right away.

Paradigm Shift Consulting we believe that education should be immersive, engaging, and interactive. That's why our webinars are designed to be just that. You'll have the chance to ask questions, participate in group breakout sessions and sit for a Q and A at the end… and if your topics are sensitive we will have a separate and private call.

Don't let GDP regulations hold you back.
Sign up for Paradigm's online training sessions and take the first step towards becoming and remaining compliant in Good Distribution Practice.
Please note that this is almost 2 days condensed to 1, is an excellent refresher for existing RPs, and a crash course in expectations for managers and quality teams.

We look forward to seeing you soon!

***20% off all courses when you use code "GDPSALE20"***

https://gdptraining.co.uk/courses/good-distribution-practice-for-rps-and-management-online-webinar/

Paradigm Shift Consulting

05/09/2022

By July 2023, ISO 9001:2015 accredited Paradigm Shift Consulting Limited will have been offering Responsible Person services, auditing, inspecting, advising and training staff in Good Distribution Practice for 10 years as a limited company (while saving more than a few licences along the way!) We became a virtual lifeboat for companies who were floundering in the choppy seas of Brexit and Covid-19.

Year after year, our client portfolio continues to grow and includes high street names, manufacturers, wholesalers, logistics companies and marketing authorisation holders.

As a company that’s Cogent Assured with full Trainer status, we have a dedicated office support team, account managers and multiple RPs, RPi’s, QA officers, Pharmacists and experts in medicinal cannabis who can answer questions or help deal with any concerns.

Our team of specialists and consultants are long term associates of Paradigm Shift Consulting, which means you would have the luxury of a long-term relationship with quality professionals who can support you as your business grows, giving those special ingredients of consistency, familiarity and reliability which can aid you in your long term strategy and development.
We are the leading Good Distribution Practice Consultancy for IAG cases and remediations, and the only consultants to offer free termination services. We won’t kick you when you’re down!

The majority of our clients have left a 5-star rating on our training platform, many with their comment or review. Here is a selection:

“I like the pre-test to highlight strengths and weakness of understanding. Then the detailed information regarding the course presented immediately to clarify your learning with the opportunity of re-taking the test to check improvements.”

“Very easy to digest the information! Thank you for creating such a great course!”

“The staff and I thoroughly enjoyed this course. It is very informative. You get to undertake a pre-assessment to evaluate your level of knowledge and the staff found it very valuable and rewarding to see a marked level of improvement in the pre-test and the final assessment. The course further helps to reinforce the staffs' understanding of the work that they are undertaking and why.”

“Presentation was good and easy to understand.”

“Course provides a good level of content for both the initiated and uninitiated alike and is the right length too …. All in all an excellent course.”

“Good content and a systematic approach to learning Good Distribution Practice”

Look out for our new GDP Driver Training and Loading Bay Operatives Courses, to be released imminently!

Visit our GDPtraining.co.uk website and have a look around! If you’d like to know more about our services, bespoke support or how we can help you, please reach out to us through our contact form at the bottom of our website page.

Welcome to a new Paradigm!