Pharma News and Articles
Read our articles on pharmaceutical regulatory developments as well as news about our pharmaceutical training courses. The 5 most recent pharma articles are shown in the slider and the rest are shown in date order below.
News about our new 3-day Responsible Person course will confidently set budding RP’s on a path to becoming qualified in a much shorter timeframe than other 2-day coursesread more
This article will consider the concept of “quality” and looks at how a range of experts in this field have arrived at various quality definitions.read more
In this article and video we look at some general systems thinking points and consider the structure of a Quality Management System together with the underlying concept of Quality Management principles – the “oil” used to maintain our Quality Management System. Taken from Unit 01 Chapter 03 of our QPharma/QP course on Quality Management Systemsread more
An audit report is an essential part of the audit and this article lists the key items that you should ensure are in your audit report contents.read more
A Quality Manual is a very useful document that not only gives guidance and direction to an organisation’s own personnel, but gives a potential customer, inspector or auditor an appreciation of an organisation from the outside. If designed well it can be used as a tool to sell an organisation, to show what a positive quality ethos they have and can show how good an organisation is and how seriously it takes its Quality Management System.read more
As with everything else in life, planning is everything. An audit is much more effective for everyone concerned if the auditor takes a short amount of time to plan the audit correctly. This article incudes a checklistlist of things to include in the planning of any effective audit.read more
Now Available - online Data Integrity training for your team Our 20-minute online Data Integrity training course will ensure your entire team understand the importance of Data Integrity and their role in meeting the expectations of EU Inspectors (such as the UK’s...read more
The European Union has published its new Directive for pharmaceutical manufacturing sites that is to replace the existing Directive (Directive 2003/94/EC) for human medicines. From having an initial look at the new Directive, here are a few comments.read more
According to pharmaceutical cGMP (current Good Manufacturing Practice) guidelines, pharma companies need to conduct regular instrument calibration as part of their validation and qualification activities. This article gives an overview of what is involved.read more
What is the difference in meaning between these words in the context of GMP?, In this post I explain, using EU GMP as my point of reference, although as you will find out, there are occasions within EU GMP where the incorrect terms have been used.read more
About Inspired Pharma
We help people in Pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure 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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Forthcoming Public Courses
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