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”.

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.

GMP Auditing Articles and News

Read our articles on GMP auditing relating to regulatory compliance in the Pharma industry . The 5 most recent articles are shown in the slider and the rest are shown in date order below.

Auditing – Opening and closing meetings – How to do them professionally

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.

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Basic audit findings and EU GMP clauses

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.

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New live online interactive format a great success

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.

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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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A Quality Manual – what is it and what should it contain?

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.

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Planning to perform audits

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.

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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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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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