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QP Quality Management Systems online course

Learn how to establish, monitor and improve a modern Pharmaceutical Quality Management System taking into account Good Manufacturing Practice (GMP) requirements and recent changes in GMP's requirements for Quality Systems. Meets UK Study Guide requirements.
Key Course informationWhy choose this course

QP Quality Management Systems online course

Learn how to establish, monitor and improve a modern Pharmaceutical Quality Management System taking into account Good Manufacturing Practice (GMP) requirements and recent changes in GMP’s requirements for Quality Systems. Meets UK Study Guide requirements.

The QP Quality Management Systems online course is available online using a desktop pc, laptop, tablet or even a smartphone. It has been designed for busy QP candidates who want to fit short 15 to 30-minute chapters of learning into a hectic work schedule and cannot afford three, four or five days out of the office. 

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Make a Booking

Book onto the QP QMS Online Course by  selecting the button in the panel shown below:

QP QMS Online Course

Available: Anytime Anywhere using a desktop pc, laptop, tablet and most smartphones

Duration: Around 25 hours online learning plus 2 tutor-marked assessments

Cost: £995 plus VAT per learner (see below for details)

If you plan to pay by credit card then you should first look at this helpful information. Payment can be made by cheque, electronic transfer, credit or debit card. Login details will be sent shortly after payment has been made.

VAT will be charged for delegates doing the course who are based in the UK. However, delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company’s national VAT number when booking. VAT will not be charged for any delegates from outside the EU.

To try a free Taster course including 3 Chapters of the programme subscribe by clicking on the link in blue in this sentence.

Key Course Information

Course overview:

This course explains how to establish, manage, monitor and continually improve a forward thinking modern Pharmaceutical Quality Management System that adds real-value to your organisation. The course covers current principles on Pharmaceutical Quality Management Systems (PQMS) and includes the FDA’s “Guidance for Quality Systems” and ICH Q10 “Guidance on Pharmaceutical Quality Systems”. These guidelines explain the evolving nature of QMS thinking, with a focus on organisational effectiveness and efficiency rather than just product quality and GMP. We also include the ramifications to a pharmaceutical company of the recently updated EU GMP Chapter 1 on Pharmaceutical Quality Management Systems and Chapter 2 on Personnel. These both have a major impact on the role of Top Management within an organisation.
Delegates will leave the course with a clear understanding of how to successfully integrate GMP, ICH Q8, 9 & 10 and ISO 9000 principles into a compliant, effective, efficient and continually improving QMS for the whole business, as well as the role of Quality Personnel in re-shaping quality thinking to move with the times to meet today’s business challenges.

Who will the course benefit?

This course is aimed at any trainee Qualified Person (QP) as it meets the UK QP Study Guide requirements. The course is also of value as part of Continuous Professional Development (CPD) for existing QPs – especially those who need an update on more recent thinking with regards to Quality Management Systems. In addition this course is also of value to any Quality Professional, especially those working in Quality Assurance and Quality Improvement roles, as the course provides an eye-opening view of modern quality management thinking.

Cost: £995 plus VAT

This cost is inclusive of tutor marked assessments halfway through the programme and at the end.

The cost includes:

  •  Access to the on-line learning platform for 6 months.
  • Course notes containing copies of slides, notes and handouts.
  • Tutor support provided.
  • A course certificate on completion of the course.

Study Anytime Anywhere:

This course is of about 25 hours duration – the equivalent to a 3-day classroom based training course. The chapters of the course are each done in your own time. Work through the course materials when you like! The course is presented in short bite-size chunks with assessments throughout to check your understanding. Tutor support is available via telephone and email. Once you are assigned to the Course you have 6 months to complete the programme.

To try a free Taster course including 3 Chapters of the programme subscribeby clicking on the link in blue in this sentence.

View the short videos below to understand more about this unique approach:

Course Contents

Unit 01: The Evolution of Quality Management Systems

  • Introduction to the course and Study Guide
  • The concept of Quality and Quality Definitions
  • The concept of Quality Management System thinking
  • The evolution of Quality Management System thinking
  • Good Manufacturing Practice – EU and USA GMP
  • Pharmaceutical principles of QA, GMP and QC
  • Traditional GMP and modern QMS thinking

Unit 02: How to Design a Quality Management System

  • The design criteria for an effective QMS
  • Comparison of ISO 9001 and GMP
  • Pharmaceutical QMS evolution
  • The FDA’s Quality System Model & ICH Q8, 9 & 10
  • Documentation systems, documents and record keeping
  • Organisational structures, reporting relationships and review
  • The design, selection and qualification of premises, equipment, utilities and services
  • The concepts associated with risk management
  • Additional guidance for those starting a new QMS

Unit 03: How to Implement a Quality Management System

  • Assigning roles and responsibilities
  • The roles of the Heads of Production & QC and the Qualified Person
  • The role of QA and their interaction with other departments
  • The roles and responsibilities of Top Management
  • Training and evaluation
  • The skills and competencies needed to provide effective GMP training

Unit 04: Half-way tutor marked assessment

Unit 05: How to Maintain a Quality Management System

  • Review of the system so far
  • Purchasing and supplier qualification
  • Supply chain, materials control, brokers, distributors and repackagers
  • Outsourcing and technical agreements
  • Production planning, scheduling and inventory control
  • Deviations and change control
  • Calibration and preventive maintenance

Unit 06: How to Evaluate a Quality Management System

  • Annual Product Quality Reviews
  • Economic and statistical indicators
  • Staff Appraisals and Performance Management
  • Management ReviewAuditing and self-inspection
  • The collection and analysis of data

Unit 07: How to Improve a Quality Management System

  • Customer complaints and satisfaction monitoring
  • Correction, Corrective Action and Preventive Action
  • Quality metrics – GMP and beyond
  • The Process Approach
  • Process based auditing
  • Internal customer focus
  • Interpersonal skills and required behaviours

Unit 08: Miscellaneous

  • Course summary
  • Viva questions and situations
  • References and useful web-sites

Unit 09: Final tutor marked assessment

Why choose this course?

The benefits of this programme?

  • Designed for busy QP candidates who want to fit short 15 to 30-minute chapters of learning into a hectic work schedule and cannot afford three, four or five days out of the office
  • We are one of the few listed providers of QP training in the UK.
  • Course notes (delegate pack) available to print and keep.
  • Do the course when you like – no need to attend on specific days.
  • Convenience – access anytime at home or at work.  All you need is internet access and a computer, iPad, iPhone or tablet.
  • Assessments throughout the course to check understanding.
  • 2 tutor-marked assessments included during the course.
  • Tutors contactable via phone or email (UK office hours).
  • The course fee is the price you pay – no hidden or extra costs of travel, accommodation and meals.
  • Why not give us a try? Others have and were really impressed. To try a free Taster course including 3 Chapters of the programme subscribe by clicking on the link in blue in this sentence.

Previous Delegate Feedback

I will definitely recommend it for other colleagues

QA Manager, GLAXOSMITHKLINE

I liked the course very much and wish to do other modules

QA Manager, ASTELLAS

This course is very helpful to understand overall QMS especially if someone has never worked in Quality Assurance department. Since I want to switch my career from QC to QA, the course has helped me a lot.  My knowledge and understanding about Quality, Quality management system, and other important aspects relating to funtionality of pharmaceutical industry have increased. I would recommend this course to others Sheetal Patel

The whole course has been extremely well structured and I have enjoyed taking it

Pharmaceutical Consultant

Also see these reviews from the independent Reviews.io website:


Our Expertise

Peter Lavis

Peter Lavis

Peter is arguably the finest Quality Management Systems tutor in the business, his enthusiasm for quality system thinking and his outstanding training abilities have gained him international praise and appeal.  He is an IRCA registered Quality Management Systems Lead Auditor.  Peter is an enthusiastic trainer with over 30 years of quality and industrial experience, including spending the past 15 years working closely with pharmaceutical organisations small and large.

Dominic Parry

Dominic Parry

Dominic Parry has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist. He worked for 4 years at Evans Medical Limited (now Novartis Vaccines) as a Production Development Scientist. He then moved to Hoechst Marion Roussel (now Patheon, UK), where he worked for 4 years as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.

Over the past 15 years, he has worked as a leading pharmaceutical GMP trainer and Quality Management System specialist. He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems.

He is generally recognised as one of the leading GMP trainers in the UK and brings an enormous amount of interest, enthusiasm and fun into the training he presents. He is Managing Director of Inspired Pharma Training Ltd.

Ron Orme

Ron Orme

Ron has been involved in the learning and development industry for over 20 years. He is a Fellow of the Learning and Performance Institute and in 2004 received the LPI ‘Colin Corder’ award for outstanding services to the training industry. He is the architect behind our website and our learning platform and also develops the web-based learning courses that we now offer to support many of our learning programmes. In addition, he also provides general business support on strategy and sales and marketing.

Find out about our course ranges

GMP Training

QMS Training

GDP/RP Training

GMP Compliance

QP Training

GDP Compliance

The Concept of Quality and Quality Definitions

This article will consider the concept of “quality” and looks at how a range of experts in this field have arrived at various quality definitions.

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

What to include in an audit report

An audit report is an essential part of the audit and this article lists the key items that you should ensure are in your audit report contents.

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.

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.

Management Review – who, what, where and when?

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?

Standards to use when auditing suppliers

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.

Data Integrity – why all the fuss?

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.

QMS News and Articles

Read our articles on  QMS regulatory developments as well as news about our QMS 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

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Forthcoming Public Courses

2019

January

21 Pharma GMP Lead Auditor

Febuary 
12 Data Integrity

March

Pharma GMP Lead Auditor Osaka, Japan
13 GMP Documentation and Records
14 Good Manufacturing Practice
18 Pharma GMP Lead Auditor
26 Responsible Person

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

For 2019 dates select the green 'See all Courses and Dates' button above or to the left.

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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