RSC approve the QA and Engineering versions of our highly effective online GMP courseRecent analysis of over 500 delegates who completed our online GMP courses in the last 6 months showed the course is very effective and with the approval from the RSC of our two new versions for QA and Engineering personnel this course is set to be of increasing value to Pharma organisations.
RSC approve the QA and Engineering versions of our highly effective online GMP course
Recent analysis of over 500 delegates who completed our online GMP courses in the last 6 months showed the course is very effective and with the approval from the RSC of our two new versions for QA and Engineering personnel this course is set to be of increasing value to Pharma organisations.
Wonderful Delegate Feedback
At the end of every online course we ask our delegates to complete a short survey with just 3 questions:
How valuable was this course?
Over 45% found the course “extremely valuable” as an introduction/refresher to GMP and it’s importance in their job. With a further 40% finding it “valuable”.
Will this course help you to contribute to your organisations quality goals?
Over 40% found the course “Will help a lot” and a further 40% said that it ‘Will help’ them to contribute to their organisations quality goals.
What are your thoughts on the style and content of the course? Are there any areas where you would like to suggest improvements to the course? Or do you have any other comments?
We had a wide range of very positive comments including:
Very good course, helped me see the importance of details in my day to day job
Clear, concise course that is great introduction for new starters and a good refresher course for
Very informative content and easy to follow with good end of chapter assessment to ensure the concept is understood.
Our QA and Engineering versions are now RSC Approved
The RSC Assessor made the following comments on these recently launched versions of our GMP online course
The GMP for QA personnel course fills a gap in the EU GMP guidelines as the role of QA is defined briefly and vaguely. The module is longer in respect to the others, but provides an easy to understand overview of the QA role and its relationship with the different processes within a QMS. It also offers a brief insight into a newer concept of improvements in GMP.
The GMP for engineer course is clear, well-structured and the information is logically presented. The role of Engineer module is definitely a value added as the management of facilities/equipment is often overlooked or not explained properly in GMP courses. The questions at the end are relevant to the topics discussed and adequate to test the understanding of the trainee.
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