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Qualified Person (QP) Pharmaceutical Quality Systems training course

This 3-day Qualified Person (QP) Pharmaceutical Quality Systems training course provides trainee Qualified Persons and other pharmaceutical quality professionals with a thorough knowledge and understanding of how to establish, monitor and improve a Pharmaceutical Quality System (PQS). The course meets all of the requirements of the UK Study Guide for trainee QP's.
Key InformationMake Booking

This 3-day Qualified Person (QP) Pharmaceutical Quality Systems training course provides trainee Qualified Persons and other pharmaceutical quality professionals with a thorough knowledge and understanding of how to establish, monitor and improve a Pharmaceutical Quality System (PQS). The course meets all of the requirements of the UK Study Guide for trainee QP’s.

It is essential that any pharmaceutical quality professional has a detailed appreciation of the workings of a GMP based Quality Management System.  This three-day course covers how to establish, monitor, manage and improve a Pharmaceutical Quality System (PQS) and is based on and includes all of the requirements of the latest UK: Qualified Person Study Guide for trainee QPs.  The course is primarily aimed at trainee QPs, but will also be of great benefit to any new Quality Manager who needs a greater appreciation of how to have a GMP compliance based Quality Management System.

By the end of this module, you will have a comprehensive knowledge of the systems required to support the oversight and control of the manufacture, testing and distribution of a medicinal product, throughout its lifecycle by implementing robust a Pharmaceutical Quality System.

Key topics covered:

  • Implementing key quality systems, including
    – Design of PQS
    – Quality Governance
    – Managing change / project management
    – Training and competency
  • Outsourcing and vendor assurance programmes
  • Embedding Quality Risk Management into the organisation
  • Auditing and inspections to relevant legislation and guidelines
  • The impact of planning and scheduling on quality and operational systems
  • Quality Engineering including validation, calibration and planned preventative maintenance
  • Leadership for the QP – developing the soft skills needed by the Quality Professional and Qualified Person

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Booking details

Select the tabs below to find out all the details you need to know to make a booking on this Qualified Person (QP) Pharmaceutical Quality Systems training course

Course cost

The cost of the QP Pharmaceutical Quality Systems training course is £1995 plus VAT. Course will be charged in GB pounds. For full details of what is included in the cost see below.

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 coming from outside the EU.

What's included in cost

The cost includes:

  • Course folder containing copies of slides and supplementary notes and handouts.
  • Course attendance certificate 
  • Full tutor support and access during course times.

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 or want to reserve a place, 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’ options 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.

Group Bookings - discounts of up to 50%

Book 2 or more individuals from the same company for the same course date to enjoy substantial discounts. The first booking is charged at the full published rate with the second booking charged at full published rate minus 20%. A third or fourth booking is charged at full published rate minus 50%. These discounts are applied automatically when you make a booking.

Key Course Information

Who will the course benefit?

This course is aimed at trainee QPs as well and anyone working in, or moving into, more senior roles with the Quality Department.  It is ideally suited to Quality Assurance personnel who need to have a greater understanding of how to have a compliant, effective and efficient Pharmaceutical Quality Systems (PQS) working well within their organisation.  The course is also of benefit to any manager working at a pharmaceutical organisation to understand their role in the overall PQS.

Course overview:

  • Philosophy and principles of Quality Assurance and Quality Management across organisations.
  • Design of Quality systems appropriate to lifecycle stage and activities performed.
  • Principles of Quality Risk Management, including hazard identification and risk mitigation, including where it can be utilised.
  • Key Elements of Pharmaceutical Quality Systems, including:
    – Quality Management infrastructure.
    – Production planning / scheduling and capacity planning, Vendor assurance including audits and technical agreements.
    – Product Quality Reviews.
    – Supply chain oversight.
    – Design, control, validation of premises, equipment and utilities.
  • Key interpersonal skill for the QP

This course is run in partnership with QP Quandary.  You can book from this website or from their website.

If you are interested in booking, click on BOOK NOW above.

Find out about our course ranges

GMP Training

QMS Training

GDP/RP Training

GMP Compliance

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GDP Compliance

Annex 1 2022 Section 10: Quality Control (QC)

This final article looks at the new requirements in section 10 on Quality Control. It is also a useful point at which to reflect on the 2022 version of annex and what might it mean.

Annex 1 2022 Section 9: Environmental and Process Monitoring

This article is covering section 9 which describes the annex 1 guidance for Environmental and Process Monitoring. Section 9 is now a centralized location for monitoring activities.

Annex 1 2022 Section 8: Production and Specific Technologies – part 3

In this final part of the article on section 8 we will look at Sterilization processes. The selection of a sterilization process should be based on scientific principles.

Annex 1 2022 Section 8: Production and Specific Technologies – part 2

This is the second part of the article covering section 8 of Annex 1 2022 and here we are looking at the requirements around Form fill seal and Blow fill seal.

Annex 1 2022 Section 8: Production and Specific Technologies – part 1

This next article in our series is about section 8, which is the largest section of Annex 1 and covers production and specific technologies

Annex 1 2022 Section 7: Personnel

In this article, we move onto the personnel section, section 7.

Annex 1 2022 Section 6: Utilities

In this article we expand upon the equipment section but looking at Utilities as described in section 6.

Annex 1 2022 Section 5: Equipment

In this article we look at the general requirements for the equipment used in the manufacturing of sterile products.

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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.

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Our Public Course range

Most of our public courses are currently being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together. In 2022 we began to once again offer traditional classroom courses - see details on each course page.

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Advanced Good Manufacturing Practice

Good Distribution Practice

Good Manufacturing Practice

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GMP Problem Solving

Responsible Person (RP)

Sterile Products

Webinar: Microbiological control in pharmaceutical production 

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See and download our Auditing Brochure detailing our courses and services in this important area.

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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