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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.

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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

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The roles of the Heads of Production & QC and the Qualified Person

In this video, we look at “The roles of the Heads of Production & QC and the Qualified Person” and what GMP’s requirements are when it comes to roles and responsibilities as well as the specific duties of these three individuals.

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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

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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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.

GMP News and articles
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Design Criteria for an Effective QMS

Design Criteria for an Effective QMS

Jan 31, 2019 | 0 Comments

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

Oct 29, 2018 | 0 Comments

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

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

Sep 4, 2018 | 0 Comments

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

Jul 6, 2018 | 0 Comments

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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Management Review – who, what, where and when?

Management Review – who, what, where and when?

Apr 26, 2017 | 0 Comments

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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Standards to use when auditing suppliers

Standards to use when auditing suppliers

Jul 4, 2016 | 0 Comments

The idea of Management Review meetings has only been a formal GMP requirement for the past 5 years or so. In the many visits that I do to pharmaceutical manufacturing sites I see these done – but rarely done well, which is a real shame. So what are these GMP Management Review meetings, why do we have them, what should be discussed, who should attend and how often should we have them?
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Data Integrity – why all the fuss?

Data Integrity – why all the fuss?

Jun 20, 2016 | 2 Comments

If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers. GMP does not really tell you what pharmaceutical supplier standards you should or could use when auditing your suppliers this post lists of all the key standards to use when auditing suppliers including links to all of the key documents and authorities.
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Problems and deviations – avoid blaming the operator

Problems and deviations – avoid blaming the operator

Jun 13, 2016 | 1 Comment

The careful and secure control of data and records has become a hot topic at regulatory inspections recently. One reason for this is the increased use of computer systems to hold data in one form or another. Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.
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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.

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Forthcoming Public Courses

September

23 Pharma GMP Lead Auditor

October

8 Data Integrity

10 Good Manufacturing Practice

15 Responsible Person

22 Advanced GMP

November

4 Pharma GMP Lead Auditor Manchester, UK

6 Documentation and Records

7 Good Distribution Practice

12 Pharma Internal Auditor

19 Sterile Products

26 Pharma Problem Solving

December

2 Pharma GMP Lead Auditor 

All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.

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Data Integrity

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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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