Pharma Induction, Refresher and Compliance trainingUse Inspired Pharma to deliver your next Pharma compliance training programme deploying either our effective online learning courses, our GMP experts or use both for maximum impact
Pharma Compliance training
The Inspired Pharma team have designed and successfully delivered major Pharma Compliance training programmes for some of the UK’s largest Pharmaceutical organisations. Consequently some years ago, to complement our own expertise in workshop style courses we built a series of online GMP and GDP compliance training courses to enable organisations to achieve regulatory compliance more cost effectively. This initiative has been very successful with many companies using our services including AstraZeneca UK, GW Pharma, MedPharm, Novartis Vaccines, Otsuka Pharma, Porton BioPharma, Proveca, Sequirus Vaccines and Thornton & Ross.
Online Pharma Compliance training
We offer a series of online GDP and GMP training modules that are used for Pharma compliance training, or as part of a Pharma induction programme. These modules can also be used as part of on-going refresher training for existing personnel. In addition, the courseware can be customised, if required, for your site or company and can be purchased for use on your own internal systems. Also recently we have added a short online course on Data Integrity
The advantages of using this training offering include:
- Access at any time (day or night)
- Access via any computer, tablet or iPhone (or equivalent)
- Built-in assessment questions and pass mark
- Can be set up to provide training data for your compliance programme
- Materials kept current and up-to-date as legislation changes
- No need for an on-site trainer
- Short modules with specific topics
- Groups can undertake modules relevant to their role
- Whether there is a large group to be trained or just a few individuals it is very cost effective
The modules/chapters last between 10-20 minutes and there are assessments for each chapter for the delegates to complete when they have finished each one. These are marked automatically by the system.
Select this link to see the full course details about the online Data Integrity course.
To try a free taster course complete the panel below and if you are interested in discussing how we can get individuals, or even your whole site, access to the GMP/GDP compliance training materials, then please get in touch. Prices depend on the number of personnel, number of units to be accessed and number of sites involved.
INTERESTING workshop-based Pharma compliance training
We have been involved in designing and delivering workshop based courses for some years now and the secret to success that we have found is to make the events INTERESTING. Our approach is explained in this article – click here to read
Of course, we can also provide any consultancy services you may require to tackle site specific issues that need to be addressed in more detail, perhaps as a result of an Inspection.
Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.
Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.
While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.
About the author
Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.
Training courses on Annex 1
There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.
Our 2-day course is updated for Annex 1 changes
Find out about our course ranges