Course Overview

  • “Instructors very responsive to questions, also outside lectures. Fully lived up to my expectations.” Jens Henrik Eilertsen / Novo Nordisk, Denmark
  • “Gave an excellent understanding of PQS and how to improve ours.” Rob Heathcote / Alliance Medical, UK
  • “Great tutors. It’s really valuable to be taught by people with so much experience of the industry.” Matthew Hall / Teva, UK
  • “Very interactive courses allowing sharing of best practices. The tutors were informative as always.” Karen Marks / Seqirus Vaccines, UK
  • “Well presented with subject experts who know their stuff with a good balance of teamwork activities and lectures in terms of time and how they were spread through the program.” Chris Geeson / Allergy Therapeutics, UK
  • “Absolutely fantastic course – interactive, excellent tutors, supportive and brilliant training material. Inspiring! Most of all it was enjoyable from start to finish! Thank you!” Anthony Wright / Reckitt Benckiser, UK

In this intensive, highly interactive 5-day course you will learn the essential elements of an effective, compliant, modern pharmaceutical quality system and how to implement, monitor and manage a system to meet the needs of all the major international regulatory agencies. Learn how to simplify systems and add value to your company, not just cost!

About This Course

A vast majority of adverse inspection findings relate to Pharmaceutical Quality Systems (PQS), this highly interactive course will help you decide if your PQS is effective, fit for purpose and working well, or if not, what to do about it!

The quality of your products depends on the quality of your people and the effectiveness of the pharmaceutical quality system. Properly functioning, your PQS should be your business management system and should drive continuous improvement and cost saving.

As QPs and quality professionals, you can’t certify or release products and stay in business unless your PQS is in control.

Attend this course if you want to:

  • Learn how to do more with less
  • Simplify your PQS to improve speed and flexibility
  • Get your questions answered

It is essential training for anyone who monitors part or all of the pharmaceutical quality system and provides invaluable oversight for senior leaders. This course meets the requirements of Annex 16 and other key EudraLex chapters and annexes.

This course is also Royal Society of Chemistry approved as suitable for their members’ CPD.
 

Key Learning Objectives

On completion of this course delegates will know and understand:

  • What is a PQS and what is in a PQS
  • Industry norms and best practices
  • QP decisions
  • How the PQS is applied throughout the lifecycle of a medicinal product
  • How to demonstrate to inspectors and management that the PQS is effective
  • The impact of culture on the pharmaceutical quality system
     

Course Outline

  • Principles and expectations of the PQS
    • Product lifecycle
    • PQS elements
    • ICH Q8, 9, 10 and the PQS
  • Senior management and the PQS
  • People – selection and development
  • Documentation – data integrity
  • Change management
  • Supply chain management and GDP
  • Facilities, equipment and services management
  • Validation
  • QP relationships and release scenarios
  • Deviation management
  • Audits and self-inspections
  • Complaints and recalls
  • PQR, management reviews
  • Continuous improvement and quality metrics

We provide an optional post-course assessment.

Who Should Attend

The Aspiring Qualified Person

  • Our training is generally considered as the best available and our QPs are held in high regard within the industry.
  • As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries, including Ireland, The Netherlands, Austria, Hungary and Malta.
  • You are more likely to become a QP with us than with any other training provider!

The Pharmaceutical Technical Professional

  • Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control.
  • Many industry professionals from a range of disciplines attend the courses as part of their Continuing Professional Development. Taken with some of our other QP modules, this course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications.

Find out why you should choose NSF for your QP training by visiting our qualified person training section

Course Tutors

Course tutors will be:

  • Liz Allanson - As an ex-MHRA GMP inspector for 18 years, Liz found the success of the inspection was ultimately dependent on the PQS. In the last ten years Liz has helped companies implement effective and compliant quality systems.
  • Rob Hughes - Rob’s experience includes the development of QA systems, the international QA strategies, the corporate PQS and the strategy for Process Analytical Technology for two major pharmaceutical companies.
  • Lynne Byers - Lynne has worked as Head of Inspectorate and Licensing for the MHRA. Lynne has an excellent understanding of the EU GMP regulations and has broad experience with the manufacture of a wide range of parenteral and non-parenteral dosage forms.

All tutors eligible to act as a QP.

Other Dates and Venues for this Course

For other dates and venues for this course, visit our course calendar

Subject Sessions

  • Teamwork: Principles of QA and PQS – Overview
  • Integration of Quality Systems Across Product Lifecycle
  • Teamwork: Quality Management System Elements
  • Teamwork: Find it Exercise in ICH Q10
  • ICH Q9 Quality Risk Management
  • Teamwork: Risk Management and PQS
  • Senior Management Roles and Responsibilities with Regard to the PQS Senior Management Roles and Responsibilities – Aide Mémoire
  • Teamwork: Senior Management Commitment to Quality
  • People
  • Teamwork: Training and Development of People
  • Documentation and Records
  • Data Integrity
  • Introduction to Change Control – Planned Changes
  • Teamwork: Change Control
  • Supply Chain Management
  • Teamwork: The Quality Management of Materials
  • Introduction to GDP - Teamwork: GDP
  • Teamwork: Design Criteria
  • Production - Production Aide Mémoire
  • Teamwork: Production and QA
  • Facilities, Equipment and Services Management
  • Validation and Qualification Systems
  • Batch Release System
  • Teamwork: Release Scenarios: To Release or Not?
  • Teamwork: QP Relationships
  • Laboratory Control Systems
  • Teamwork: Deviation Management
  • Teamwork: Audits
  • Audits and Self-Inspections
  • Teamwork: Evaluation

Course Fees

Course cost (excluding VAT)  £3,395.00

DISCOUNTS AVAILABLE

Multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators,
charities and some self-funding individuals – contact us for details.

Have a question or want to book a place? Contact QPpharma@nsf.org - you can also register online by clicking below.

Register