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    2017 course dates

    Our public course dates for 2017 are now available along with the remaining dates in 2016

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    Launch of short on-line GMP course

    Now available – a 1-hour on-line course designed to introduce people new to the pharmaceutical industry to the main requirements of Good Manufacturing Practice with versions for Warehouse, Packaging and Manufacturing personnel

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    Japan PQMS Lead Auditor 2016 dates

    Following last years very successful first delivery of our Pharmaceutical Lead Auditor training course in Japan, I am pleased to announce that the 2016 course is taking place on Monday 26th September finishing on Saturday 1st October 2016 in Osaka.

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  • Good Distribution Practice

    Launch of short on-line GDP course

    This one-hour course is designed to provide people new to the pharmaceutical industry with an appreciation of the main requirements of Good Distribution Practice and/or for refresher/compliance training.

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  • QP Training Study anytime anywhere

    Qualified Person – study anytime, anywhere

    Designed for busy QP candidates who want to fit short 15 to 30 minute chapters of learning into a hectic work schedule and cannot afford whole days out of the office. Access using your pc, laptop, iPad…

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    Pharmaceutical QMS Lead Auditor Training

    Europe’s leading and most successful IRCA registered Pharmaceutical Lead Auditor course – feedback includes “A fantastic experience”, “Wow – brilliant”, “Recommended to anyone within the Pharma industry”

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  • Range of Pharma QMS courses

    QMS Courses

    We offer a range of highly interactive and modern thinking Quality Management related training courses aimed at individuals involved in creating, monitoring and evaluating pharmaceutical quality systems

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How we can help you:

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Pharmaceutical QMS Lead Auditor Training

Europe’s leading and most successful IRCA registered Pharmaceutical Lead Auditor course – feedback includes “A fantastic experience”, “Wow – brilliant”, “Recommended to anyone within the Pharma industry”

Range of Pharma QMS courses

QMS Courses

We offer a range of highly interactive and modern thinking Quality Management related training courses aimed at individuals involved in creating, monitoring and evaluating pharmaceutical quality systems

Recent articles about GMP

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Standards to use when auditing suppliers

If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers. These could be suppliers of chemicals and packaging components, as well as suppliers of analytical testing or calibration services. GMP does not really tell you what standard you should or could use when auditing your suppliers, so below is a list that may be useful.

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EU GMP Chapter 9: Self-Inspection – time for an update?

In the past few years eight of the nine chapters of EU GMP have been updated. However, Chapter 9 has not been updated at all. This is strange as GMP’s stance on Quality Management System thinking has evolved a lot of the past few years, so surely the requirements for the number one mechanism that you have to evaluate this system should be updated too? Here are my thoughts

Computer Systems Validation

Data Integrity – why the fuss?

The careful and secure control of data and records has become a hot topic at regulatory inspections recently. One reason for this is the increased use of computer systems to hold data in one form or another. Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.

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Duties of Key Personnel

Some of the most popular articles on our blog are the four we published some four years ago about the duties of key personnel in GMP. For more recent visitors to the blog I thought it might be helpful to remind everyone about this resource.