QMS News and Articles
Read our articles on QMS regulatory developments as well as news about our QMS training courses. The 5 most recent pharma articles are shown in the slider and the rest are shown in date order below.
This course has already run very successfully on an in-house basis for our clients who are increasingly concerned to ensure that they comply with the latest regulations from the EU and the FDA regarding the data integrity of their systems.read more
Chapter 8 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.read more
Chapter 5 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.read more
Chapter 3 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.read more
Hot off the press – find out more about new guidance from the MHRA on GMP data integrity expectations for the pharmaceutical industry.read more
Here is a free template for things that you should include in an auditing closing meetingread more
Here is a free template for things that you should include in an auditing opening meetingread more
A new update to EU GMP Chapter 2 has been issued and comes into operation on 16th February 2014. Here is a summary of the main changes.read more
I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records. This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.read more
A new challenge for all auditors – being asked to perform an audit in a foreign country, where you don’t speak the local language! How should this be tackled?read more
About Inspired Pharma
We help people in pharma organisations to continually improve their systems to gain competitive advantage and ensure regulatory compliance.
We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for inhouse delivery at a client site.
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