Coronavirus – an update about our public course training programme
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Update 20th July
Due to the uncertainties involved in travel now, and especially the risk of local lockdowns, we will be delivering all our courses using our proven ‘live online interactive’ technology. Delegate feedback from the courses we delivered in June and July has been just as positive as our classroom courses and in addition, many people have enjoyed not having to travel in these challenging times.
Update 6th July 2020
With the easing of restrictions, and after discussions with our venue providers, we are pleased to announce that our classroom courses will start running again from September 2020. To comply with social distancing class sizes have been reduced to a maximum 8 or 9 delegates dependent on the room size. See 20th July Update.
Update 26th May 2020
We have been busy over the last two months building our skills and know-how to deliver inspirational instructor-led virtual training classes and we are pleased to announce our first public courses that will run in July:
- Virtual GMP course– 3 90-minute sessions over 3 days 7-9th July
- Virtual Problem Solving and Root Cause Analysis – 4 90 minute sessions on 14th July
With 2 expert facilitators and a maximum of 8 delegates our public courses will utilise state-of-the art virtual classroom software that will enable you to:
- chat online with the facilitators and other delegates
- raise your ‘virtual’ hand to ask a question
- participate anonymously in a poll or survey and see an instant display of the class results
- undertake exercises on your own or in a group
Sessions will last no longer than 90 minute with breaks of at least 30 minutes in between. As always we will seek to make our virtual courses inspirational, enjoyable and educational.
In addition, we are working with some of our clients to deliver in-house virtual courses – get in touch with us if you would like to know more.
We hope to resume our ‘socially distanced’ classroom courses in September but this may not be possible – so we are gearing up to switch to virtual delivery if this is required.
Update March 24th 2020
It is with regret that, with the current Coronavirus crisis, it is impossible to continue to run our schedule of classroom-based training courses for the foreseeable future.
As a result all our public training courses scheduled to run between now and 1st September 2020 are cancelled.
Existing delegates will be transferred to the next course that they find convenient or offered a credit note/refund if that is what they would prefer
I will also be looking to see what we can do with regards to on-line/ virtual offerings in the next week or so.
As a company we are financially strong and will survive this, but for the time being this is all that we can do.
Thank you for ongoing support and all the very best for you and your families in this difficult time.
Original Article March 5th 2020
Several of our delegates have been in touch to tell us that they cannot attend a forthcoming public course they are booked on because of a company travel ban. Also, some people are contacting us to ask if we are still running a course that they are booked on or plan to make a booking on.
So, this article is aimed at updating people booked on a course or thinking about booking a course on our current approach to this difficult situation.
Firstly, if anyone is booked onto a course in the next couple of weeks or months and can no longer attend the course, we are offering to move that booking to a course later in the year when the current crisis will be over (we hope). We are taking this approach even where our normal cancellation terms would indicate that there would be a financial penalty.
Secondly, if a course date is advertised on our website then you should assume it is our intention to run this course. As soon as we believe the course is no longer viable, we will remove it from our website. As we speak, all of our courses though to June are viable and should take place. If there are cancellations from these events and we decide not to run a particular course then we will either move the remaining delegates to a later course or refund the course fees, whichever they prefer.
So, if you are planning on booking on a course, you should have no reason to worry that there might be a financial penalty if a company travel ban or some new government restriction might mean you cannot attend.
And, if you are already banned from travel or you simply do not want to travel at this time, from personal choice, then you might like to consider online learning as an alternative means of developing your talents. If you need to improve your knowledge of Quality Management Systems our online course might be ideal for you. Or if you need to improve your knowledge of GMP or GDP then you should also consider our RSC ‘Approved Training’ online courses in these areas. And if you are a budding QP, then our online courses may also be of interest. Select the links below to find out more.
And, if travel becomes very difficult, we may offer some virtual classroom courses to bring our inspiring training to your desk or home. Let us know if you would be interested in this style of learning.
And, we can deliver any of our courses at your site if there are sufficient people who need this training.
These are difficult times for everyone, but we hope to help as many people as possible to achieve their development goals during this period.
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