Changes to our GDP Training Courses

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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 excellent refresher, or intensive course for pharmacists, managers or staff very involved in GDP.

Day Two will allow us to cover more information and go into further detail in certain topics than we could before as well as using practical activities to aid understanding. There will be practical sessions on Quality Management Systems, Standard Operating Procedures and Process Mapping, Deviation management, Corrective and Preventive Action and Change Controls.

There will be videos, practical sessions and a common sense approach to the often challenging regulations.

 

Expected Outcomes for the Two Days:

– You will learn what the 10 working Chapters of EU GDP 2013/C 343/01 mean and how to satisfy the requirements in a compliant manner.

– You will learn about the MHRA Inspection, Enforcement and Standards team, the Compliance Management Team and Inspection Action Group.

– You will have an understanding and practical application of deviation management, Corrective and Preventive Actions (CAPA) and Change Control.

– You will have a better understanding of warehouse operations, temperature controlled shipping, mapping and be able to discuss your own site with a working RP (unlike some other companies).

– You will have a better understanding of complaints, and trending of outsourced activity performance.

– You will understand your legal requirements as a Licence Holder and Responsible Person under the Human Medicines Regulations 2012, relating to wholesale of medicines and falsified medicines.

In all, we will do our best to cover EVERYTHING, although you must realise that many of the topics could be a two or more day course on their own, especially transport, export, qualification and validation, temperature mapping and temperature controlled boxes.

 

We want to be able to give you as much knowledge and help as possible!

The hands-on activities aid in learning outcomes, and the extra time means that you will have more opportunities to discuss your own compliance requirements, and we will do our best to fill in any gaps in your knowledge.

Pre and post training tests are completed to show your progress and improved knowledge.

 

The cost of the course is just £1,095+VAT per person and a discount can be given if more than one person from the same company will be attending the training.

To attend for just the first day (which will not include the practical experiences/activities or extra information/detail) the cost is £595+VAT.

Although we do offer attendance of just the second day, you will require the GDP information that’s provided on day one to have sufficient knowledge and ensure competence/compliance so we highly recommend that you attend both days – unless you have already had a Day 1 course with us and are just wanting to further your knowledge.

 

You can now book and pay online for a place at one of the courses – to do this select the date on the training calendar that you wish to attend and then click ‘find out more’, or go to our products page where you can choose the training course you want.

You can also email us at info@paradigmshiftconsulting.co.uk to make enquiries and ask any questions you may have – if you would like to get the discount code for multiple attendees, this will have to be done via email at this time.

If you (or your colleagues) are unable to attend any of these dates, contact us via the email address above and we can try to arrange another session on a separate date – if there are multiple people that need to be trained we may be able to provide the training at your site.

We may also be able to arrange a 1 day intensive course for you as we understand that it’s not always possible to take 2 days away from work.

 

If you are over an hour away from our office, we recommend staying at a nearby hotel overnight to prevent excess travel and ensuring that you don’t miss anything due to traffic or tiredness. Discounts can be given if an overnight stay is required, especially if it is for more than one attendee.

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