2018 saw an increasing number of overseas delegates attending our UK and Ireland public course programme. We also conducted a number of consultancy assigments in the US and the Far East as well as delivering many onsite courses to overseas subsidiaries of our UK pharma clients. And we succesfully delivered our 5-day Pharmaceutical GMP Auditor / Lead Auditor course in Japan. So, we are excited that this new year takes us to new shores, as we also now plan to export our expertise to the Middle East and India.

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 courses 

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.

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 Systems

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.

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.

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.