QP Quality Management Systems online course
Course Overview
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.
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.
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.
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 12 months to complete the programme.
To try a free taster of this course including 3 Chapters of the programme visit this page.
Course Content
Unit 01: The Evolution of Quality Management Systems
- Introduction to the course
- 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
- References and useful web-sites
Unit 09: Final tutor marked assessment
Make a Booking
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)
View the short videos below to understand more about this unique approach:
Course Cost
£995 + 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.
Payment
Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.
If you plan to pay by credit card then you should first look at this helpful information.
Alternatively, if you want to discuss any aspect of this training course then please send an email with your enquiry or call +44 1635 866699.
Based outside the UK
If so, be sure to pick the “Tax Exempt” option in the payment method list when you are making a booking. If you are based in the EU then you must also enter your VAT number to qualify to be exempt from VAT.
Meet the expert tutors

Dominic Parry

Peter Lavis

Ron Orme
Recent independently verified delegate reviews
Viewers also looked at these related courses
-
The use of Artificial Intelligence (AI) in a regulated environment
Live Online Interactive1 Day- £950 + VAT
Our expertise
Training Courses
Events
Resources
Consultancy
Resources
Get in touch
Inspired Pharma Training Ltd,
5 Westbrook Court, Sharrow Vale Road,
Sheffield, S11 8YZ, United Kingdom.



