For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699 info@inspiredpharma.com

The benefits of being IRCA registered

Our 5-day Pharmaceutical GMP Auditor/Lead Auditor Course is registered with IRCA, the International Register of Certificated Auditors (IRCA Ref:PR325).  This is the world’s premier organisation for professional auditors and sets down minimum standards for auditors and auditor training courses.

Raising non-conformities

Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit.  This is somewhat of an old-fashioned way of auditing.This article the best way of dealing with non-compliances using modern standards.

Documents required by USA GMP (21 CFR 211)

The article covers the requirement of written procedures required by 21 CFR 211

Documents required by EU GMP

The list below details the documented procedures specified as being required by EU GMP. It is worth pointing out that many times in GMP there is a requirement to have a “procedure”, but this is not the same as a “documented procedure”.

GMP Calibration

Around a pharmaceutical manufacturing site there will be many measuring devices that require calibration. GMP requires the calibration of such devices with similar requirements in both EU and USA GMP

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.

The importance of assigning GMP roles and responsibilities

The importance of assigning GMP roles and responsibilities

The video in this article is part of a unit in our online QMS courses that looks at how to implement a Quality Management System and, in this video, we look at the first principle associated with such implementation – that of adequately assigning roles and responsibilities.

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Successful Japan Lead Auditor course

Successful Japan Lead Auditor course

We successfully delivered our highly praised GMP Auditor/ lead Auditor training course in Osaka, Japan, for the third time a few weeks ago. The course will be presented again in Osaka next year in early March 2020

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Design Criteria for an Effective QMS

Design Criteria for an Effective QMS

Most of you will already have a QMS that has already been designed so  the contents of this video will help you to consider how you can evolve an existing QMS to cope with new regulatory requirements, QMS ideas and business pressures. In this video we begin to examine...

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The Concepts behind Modern QMS Thinking

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

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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.

Quick Links

Find your way quickly to any part of our website by selecting any of the links in this section:

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 began to once again offer 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

Good Distribution Practice

Good Manufacturing Practice

Internal Auditor

GMP Problem Solving

Responsible Person (RP)

Sterile Products

QP Courses - full range

See and download our Auditing Brochure detailing our courses and services in this important area.

Online courses available anytime anywhere 

Data Integrity

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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