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Quality Management Systems course

This 2-day 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.Now available on an in-company basis only

Our two-day Quality Management Systems course is now available on an in-company basis only.

An online course is also now available.

Course overview:

This Quality Management Systems 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 of 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 anyone working in pharmaceutical Quality Assurance who need to know how to establish, maintain, monitor and improve a modern Quality Management System that focuses on product quality, compliance to GMP and the needs of the business.  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.

NOTE – an online version of this course is also available as well as a version for trainee Qualified Persons (QPs).  The online version covers some additional content as required in the UK QP Study Guide.

Course location:

Available in-company at a venue of your choice

Course cost:

If you would like to discuss your requirements and get a quotation please send us an email

Previous feedback:

“Tutors were very knowledgeable and enthusiastic”
QA Officer, TEVA RUNCORN

“Excellent – I learnt an awful lot”
QA Officer, TEVA RUNCORN

“Tutors are brilliant”
QC Analysis, NORGINE

“Intense – but delivered so well I enjoyed it”
Shift Leader, NORGINE

“Thank you very much for an enjoyable 2-days”
QA Officer, CATALENT

“Lots to take in – intense but enjoyable”
QA Officer, CATALENT

“A completely new way to look at the QMS”
Quality Manager, AMDIPHARM

“Both trainers were very enthusiastic”
Quality Systems Executive, AMCo

“A really helpful and interesting course”
Quality Officer, AMDIPHARM

Dates:

Only available in-company

Times: 

A 2-day course with start times as follows:

Day 1:  09.30 – 17.00        Day 2:  09.00 – 16.30

Tutors:

Peter Lavis

peter

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

dom

Dominic is a highly respected GMP trainer with extensive GMP and Quality Management System experience, his reputation for delivering high-quality training courses is recognised worldwide. He has been involved in presenting inspiring GMP training courses for over 10 years with outstanding feedback received.  He has over 20 years of pharmaceutical experience in Production, Quality and more recently Training and Consultancy roles.  He is a Director of Inspired Pharma Training Ltd.

Course contents (can be customised):

Day 1     Quality Management Systems – foundations

  • Quality principles & definitions
  • The evolving concept of Quality, Quality Assurance, Quality Control and Quality Management System thinking
  • Good Manufacturing Practice and Quality Management
  • Principles and structure of EU GMP.
  • Quality Management in EU GMP – the “traditional stance”
  • Evolving Quality Initiatives
  • The Drivers and Shapers of Change
  • Quality Management Systems and ISO 9001
  • Ramifications on GMP
  • GMP Quality Evolution – ICH Q8, 9, 10 and FDA Guidance
  • Updates to EU GMP Chapters 1 & 2

Day 2     Quality Management Systems – evaluation and improvement

  • A revised role for the Quality System
  • The role of Senior Management
  • A revised role for Quality Assurance
  • Batch review and Product Quality Review
  • GMP metrics – Deviations, Corrective Actions and Complaints
  • Process monitoring
  • The internal audit mechanism
  • Customer Focus and Continual Improvement
  • Correction, Corrective Action, Preventive Action and Root Cause Analysis
  • The importance of clear Roles and Responsibilities
  • The importance of good communication
  • Good documentation
  • The importance of training and evaluation

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  GDP regulatory developments as well as news about our GDP 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

November

13 Internal Auditor
20 Sterile Products
27 Problem Solving

December

03 Pharma GMP Lead Auditor Now Full

January 2019

21 Pharma GMP Lead Auditor

Febuary 2019
12 Data Integrity

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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