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.
Inspired Expanding Overseas
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.
NEW: Responsible Person course scheduled for 2019
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
The Concept of Quality and Quality Definitions
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.
The Concepts behind Modern QMS Thinking
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
What to include in an audit report
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 – what is it and what should it contain?
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.
Planning to perform audits
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.
Ensure your team understand the importance of Data Integrity
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...
New EU GMP Directive published
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.
What Pharma Companies Need to Know about Measuring Instrument Calibration
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.
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.
Other Topics
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Quick Links
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Forthcoming Public Courses
2020
Public schedule cancelled until end of August due to COVID-19
September
7 Pharma GMP Lead Auditor
15 Documentation and Records
16 Good Distribution Practice
21 Pharma GMP Lead Auditor London, UK
22 Advanced GMP
October
06 Responsible Person
06 Data Integrity
12 Pharma GMP Lead Auditor Manchester, UK
20 Good Manufacturing Practice
21 Sterile Products
November
10 Internal Auditor
24 Problem Solving
30 Pharma GMP Lead Auditor
All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.
Online courses available anytime anywhere
Good Distribution Practice (GDP)
Good Manufacturing Practice (GMP)
Pharma Quality Management Systems module
QP Medicinal Chemistry & Therapeutics module
QP Quality Management Systems module
Each course typically consists of 10-20 minute chapters of content followed by a quiz based assessment. The QP courses feature tutor assessment too. The learning is accessed over the internet using desktop computers, laptops, tablets and even smartphones.
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