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.
Dealing with problems – for good
Problems happen in work and in life. Problems also happen within any quality system. GMP requires problems to be dealt with correctly.
CAPA – time for a rethink?
Most manufacturing sites these days have CAPA systems – a mechanism to capture, record, control and approve or reject Corrective Actions. However despite this approach many organisations feel that they are still in “fire-fighting” mode – always dealing with yesterday’s problems rather than preventing future issues from occurring.
ISO 9001 versus GMP – Part 2
One of the main problems of comparing GMP and ISO is that the two standards are not the same and are not really trying to do the same thing. This article highlights the key differences.
ISO 9001 versus GMP – Part 1
ISO 9001 versus GMP – this article lists the clauses of ISO 9001:2015 identifying requirements of ISO that are not specifically mentioned in EU GMP
Quality Assurance or Quality Control?
Quality Assurance or Quality Control? This article outlines the importance of these functions and areas where there may be some overlap.
The Focus of Audits – Have we got it right?
The focus of audits : as a pharmaceutical trainer, auditor and consultant I meet a lot of auditors and look at audit mechanisms a great deal. My impression is that the focus is not always right.
Auditing – Opening and closing meetings – How to do them professionally
No matter what type of audit you are involved in it is essential that it starts and finishes well. Opening and closing meetings offer the forum to do this. A well run and professional opening meeting sets the scene for the audit and, if done well, creates a great first impression. Likewise, a well run closing meeting draws the audit to a close in a professional and controlled manner.
Basic audit findings and EU GMP clauses
This article lists a number of common basic audit findings and the corresponding clause in EU GMP that is relevant. Readers should note that there is often some repetition in GMP, so I have tried to find the best single clause.
Exciting news – the classroom returns
News Update – traditional classes to complement our ‘live online interactive’ format; new January date for Lead Auditor course; new versions of our online courses.
New live online interactive format a great success
All of our training courses are now being delivered using our ‘live online interactive” format. Making the transition away from classroom delivery has been challenging especially for the team delivering our highly successful and intensive 5-day Pharmaceutical GMP Lead Auditor course. But the reviews in this article show how we have risen to that challenge.
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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Our Public Course range
Most of our public courses are currently being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together. In 2022 we will also begin to offer some traditional classroom courses - see details on each course page.
Click on course name for full course details and dates:
Pharmaceutical GMP Auditor/Lead Auditor
Advanced Good Manufacturing Practice
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.