About This Course

Do more than just reduce costs. Learn how to simplify systems and add value to your company. In this intensive, highly interactive four-day course you learn the essential elements of an effective, compliant and modern pharmaceutical quality system (PQS). We show you how to implement, monitor and manage a quality system that meets the needs of all major international regulatory agencies.

As QPs and quality professionals, you cannot certify or release products and stay in business unless your PQS is under control. A vast majority of adverse inspection findings relate to the PQS. Our course helps you decide if yours is effective, fit for purpose and working well or if not, you will learn what to do.

The quality of your products depends on the quality of your people and the effectiveness of the PQS. A properly functioning PQS should be a business management system that drives continuous improvement and cost savings.

Attend this course if you want to:

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

Pharmaceutical quality systems training is for anyone who monitors all or part of a PQS. In addition to providing invaluable oversight to senior leaders, this course meets the requirements of Annex 16 and other key EudraLex chapters and annexes.

This pharmaceutical quality systems course is Royal Society of Chemistry approved as suitable for its members’ continuing professional development.

Key Learning Objectives

On completion of this pharmaceutical quality systems training 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 PQS

Course Outline

  • Principles and expectations of the PQS
    • Product lifecycle
    • PQS elements
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (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 Good Distribution Practice (GDP)
  • Facilities, equipment and services management
  • Validation
  • QP relationships and release scenarios
  • Deviation management
  • Audits and self-inspections
  • Complaints and recalls
  • Product quality reviews (PQRs) and management reviews
  • Continuous improvement and quality metrics

Who Should Attend

The Aspiring Qualified Person

  • Our PQS training is generally considered as the best available and our QPs are held in high regard in the industry.
  • As well as being accepted in the UK, our training courses are well known and accepted by several 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 in 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.

Course Tutors

Course tutors will be selected from the following:

Catherine Kay - Catherine is eligible to act as a QP and has gained experience in both quality assurance and operational roles within the pharmaceutical industry. She was responsible for the start-up of a new solid dose manufacturing and packaging facility, where designing an effective PQS from the outset was key.

Erika Notman - A microbiologist by training, Erika has over 25 years’ experience in the pharmaceutical industry, holding senior roles in both quality control and quality assurance. She is eligible to act as a QP and has expertise in auditing and training of both sterile and non-sterile products.

Ian Ramsay - Ian has over 13 years’ experience in the pharmaceutical industry, most recently as a GMP/GDP inspector with the MHRA. Ian also has significant experience with QC and remediation activities and has spent significant time in frontline QA roles supporting a range of products and dosage forms.