Refresher Training: Why is it needed?

The Responsible Person, Management, and personnel of any business with a WDA licence are expected to take refresher training and continual professional development on Good Distribution Practice, to maintain compliance. It is the management’s responsibility to ensure that relevant and regular refresher training (annually at a minimum, with role specific and relevant training the ideal) takes place, to gain or maintain competence. This will help the company in remaining GDP compliant, and remain abreast of changes in regulations that may occur within the Human Medicines Regulations (2012), as amended, the GDP Guidelines (2013/C 343/01) or, for example, Brexit and the Windsor Framework.

“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.”

EU GDP Guidelines 2013/C 343/01 (Chapter 2.4)

“My role in GDP is quite small. Do I need refresher training?”

Absolutely. Everyone working within a GDP environment regardless of their operational role should take role specific refresher training, over and above any additional training required in the event of a change in procedure or regulation. Medicines and medical devices pass through many hands during the supply chain journey. Every single person must be GDP aware or, “GDP-Conscious”. It helps protect the product and ultimately the patient.

Paradigm Shift Services

If you’ve not attended GDP training (or refresher training) with us before, you can create an account with us for free, with no annual fees. You only pay for the training you undertake.

• Company Training/Personnel Managers

If you are in a management role that involves overseeing the training of staff (such as a training coordinator or an RP), you can set up an account in the usual way, but also be made a group leader. We can create a company portal for you which (once your staff are registered with individual accounts within our platform) will allow you to designate staff members to training courses yourself. The portal also gives you access to the training progress of staff, certificates (which is a document required at inspections as evidence of training) and more. This method facilitates discounts for group/batch orders of training places that we may have on offer at any time.

• Individual / Solo Users

Although most are attached to a company who will organise training for them, it is perfectly possible to undertake training with us as an individual. For example, you may be looking for work and need to keep your training up to date, to present current evidence of training (our certificates) to your potential employer. This is always a big advantage, especially if the training (or refresher training) has been provided by a Cogent-assured training facility such as Paradigm Shift Consulting Ltd.

Why is it important?

There are many avenues where you can get “training” such as Youtube videos and channels. However, training and subsequent refresher training is of no use unless it can be demonstrably verified with certification by a UK based approved and registered training vendor, such as Paradigm Shift Consulting Ltd. A printed certificate is required to be available to all inspectors and auditors because it is admissible evidence of training.

An electronic copy is also a good idea, but these days it is getting easier to falsify documents digitally. A hard copy of the certificate issued by the vendor, or their training platform, is required. This has to be up to date, which means refresher training is needed every year.

If you cannot produce sufficient evidence of succesful training and competence, the regulations state that you are not permitted to do your job until you have attained it. Failing to ensure that you have sufficient competent personnel will earn you a major deficiency in the event of an external or regulator-led inspection.

Online Webinar GDP Refresher Training

Every month (usually the third Wednesday), we conduct an online all-day Webinar for RPs and Management (although anyone could join in), which covers all ten chapters of the Good Distribution Practice guidelines, as ascribed by 2013/C 343/01 and the HMR (2012), as amended. This covers around 70% of the Gold Standard, is operations based, and is Cogent Assured and delivered by Cogent Assured trainers. This training is an excellent headstart for new senior management, or refresher for existing RPs.

What is the online refresher training like?

It is set up to be interactive and informative while being easy to digest, due to each operational aspect of GDP being presented as separate subject matters. There is always time for Q&A afterwards and a 4 week period in which to complete the final post-webinar assessment test. (There is a similar pre-webinar test which is intended to find out where your GDP “sense” is, while at the same time giving you a good idea of what to expect).

Further Training and Support

Paradigm Shift Consulting Ltd is an award-winning ISO 9001:2015 accredited and Cogent-assured training provider, offering a wide range of GDP courses for all personnel, management, and RPs. Everything is available online throughout the year. Paradigm have a highly skilled and experienced team of consultants and RPs, with specialists in all areas relating to pharmaceutical GDP. We are based in East Northamptonshire (central UK), with phone lines open from 9am to 5.30pm Monday to Friday (except for bank holidays).

We’re here to help!

If you want to know more, need assistance setting up an account, require training or refresher training, or you’re in management and you need further (or more technical advice) in any way, do not hesitate to call us or drop an email to us with your query. Take a moment to browse our courses on this website (GDP Training Courses button) or visit the Paradigm Shift Consulting website, where you will find additional useful posts and blogs. You can also message us directly using the contact form below.