“Wow – Amazing – World Class” – “truly inspiring training”
Amazing feedback on our courses
Our IRCA registered Pharmaceutical GMP Auditor/Lead Auditor Course continues to received outstanding feedback from delegates. The words in the headline above are just an extract of the review of one of our delegates – see below for some more reviews or click here to see them all. The course is available either as:
- A ‘live online interactive’ format enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together.This has also enabled delegates from around the world to attend the course without the inconvenience of overseas travel.
- Or, as “in-person” venue-based classroom training events
Visit our course page for more details and all the events scheduled for 2022 and 2023.
Fresh faces at Inspired
Over the last couple of months our delegates have met with some new members of our permanent and associate training team:
Richard worked for 22 years at GlaxoSmithKline focusing primarily on late-stage Research and Development and new product introduction into commercial manufacturing facilities. Richard has a proven track record in making major contributions to new product launches. He has a significant knowledge of global regulatory requirements, stability, analytical validation/transfers and conducting laboratory & manufacturing investigations. In addition, he has led numerous QMS projects and his audit experience spans fronting aspects of FDA and MHRA inspections, assessing Third-Parties and leading internal inspections. He has devised and delivered highly impactful training on a wide range of topics including method techniques, Laboratory investigation and Root Cause Analysis for complex problem solving. Richard brings a broad range of recent industry experience and knowledge to the training arena, a subject to which he is very passionate.
Ruth has over 35 years’ experience in the pharmaceutical industry beginning in analytical R&D and Quality Control functions before transitioning to Quality Assurance in 2002. She became a full time Global Quality GMP auditor in 2007 for a biologics company, conducting internal manufacturing and external supplier audits. Most recently Ruth gained experience in Good Clinical Practice and Good Pharmacovigilance practice Quality systems and has led audit and inspection management activities for all GxPs. In 2016 she resumed her full-time audit career as a global quality auditor and after 2 years of extensive global travel and GMP/GDP audits, she held the position of Director of Global Quality managing a team of GxP auditors and promoting improvements to the audit quality systems and working practices.
‘Evergreen’ articles updated and refreshed
When Inspired was first set up a lot of really useful articles were published on key topics in the pharmaceutical industry. Many people still read these articles but because they were published over 10 years ago some readers have queried their validity today. Consequently over the last 3 months some of these articles have been reviewed and updated. They include:
- Basic audit findings and EU GMP clauses
- Auditing – Opening and closing meetings – How to do them professionally
- The Focus of Audits – Have we got it right?
- Quality Assurance or Quality Control?
- ISO 9001 versus GMP – Part 1
- ISO 9001 versus GMP – Part 2
- CAPA – time for a rethink?
- Dealing with problems – for good
- GMP Calibration
- Documents required by EU GMP
Just click on the article in this list to see the full text.
Please feel free to contact us at email@example.com with any comments on our courses, website or any areas where we may be able to help you in some way.
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