For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699 [email protected]

GxP and GMP Consultancy

We provide clients globally with GXP and GMP Consultancy expertise including auditing services, inspection preparation, Inspection remediation and QP release

GXP and GMP Consultancy

As well as offering training courses we also provide pharmaceutical GxP and GMP consultancy and auditing services.  For this we only use leading industry specialists.  Specialists who not only have a great deal of experience but also have practical skills and ability to get issues sorted.  Our idea is that our consultants should be able to work with you and help you, rather than create even more work for you!  We can help with the following areas of the pharmaceutical industry:

Auditing service

We perform supplier audits as well as internal audits against most recognised pharmaceutical standards.  We use specialist sector-specific auditors as needed, including experienced IT/ Computer System auditors.

Inspection preparation

We help get sites ready for Regulatory and Corporate inspections, including working with groups to get their own areas ready.  We can also assist behind the scene during the inspection itself.

Inspection remediation

Not all audits go well, and we can help get sites that have had poor inspections back on their feet.

 Qualified Person release

Many of our consultants are eligible to act as Qualified Persons (QPs), and so we can provide locum QP support when needed.

Recent projects have included:
Selecting possible new manufacturing site in Asia
  • 5 sites in Malaysia were identified as possible manufacturing sites for a new medicinal product.
  • All were audited to GMP (to look for compliance), suitable technology transfer skills and the ability to supply product on time.
  • A short list was created and on-going partnership discussions continue.
Selecting possible supplier of an Active Pharmaceutical Ingredient
  • A number of potential sites in Asia were identified.
  • All were audited to API GMP.
  • A short list was created and business discussions continue.
Support for development of European QA Managers
  • A number of new QA Managers at Country Business Units (Affiliates) around Europe have been supported over the past 5 years.
  • Many were new to GMP.
  • Included audits of their offices and gap analysis against company requirements.
  • Followed by support and ongoing training and development.
  • QA Managers now have a much greater appreciation of the rules and regulations of EU GMP.

If you would like to find out more please send an email with your details and we will be in touch.

Find out about our course ranges

GMP Training

QMS Training

GDP/RP Training

GMP Compliance

QP Training

GDP Compliance

Travel difficulties – online learning may be the answer

With many organisations banning travel, or individuals simply making a personal choice not to travel, online learning can be a valuable way to keep building the skills and knowledge needed for your continued success. 

Coronavirus – an update about our training course programme

We are hearing from several of our delegates that they cannot attend a forthcoming public course they are booked on because of a company travel ban . Also, some people are contacting us to ask if we are still running a course that they are booked on or plan to make a booking on. So, this article is aimed at updating anyone booked on a course or thinking about booking a course on our current approach to this difficult situation.

Our most popular GMP and QMS articles

This article highlights some of our most popular articles

Does your organisational culture “get” data integrity and it’s importance?

 The MHRA’s GXP data integrity guide was published in March 2018. ‘GXP’ refers to the various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority...

The Golden Rules of GMP – a free GMP video

This free GMP video lasts less than 2 minutes and you can download it for your personal use OR as a part of any refresher/compliance training programme you are running in your organisation providing you leave the opening and closing credits part of the video.

Guidance for starting a new QMS for a Pharma organisation

This article offers detailed advice for those people working in the Pharma secor who are facing the daunting task of starting a new QMS for the first time.

Pharma supplier selection, approval and management

In this article we explore the controls needed to both approve Pharma suppliers and to control the purchasing of materials from them

The 2018 MHRA GDP Symposium

For those of you who did not attend the 2018 MHRA GDP Symposium or missed their recent blog the key highlights are in this article

Pharma News and Articles

Read our articles on  Pharma regulatory developments as well as news about our Pharma training courses.

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.

Quick Links

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

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

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.

Why not subcsribe to our mailing list to try a free Taster  of these courses to see if they are of interest?

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