Course Overview

  • “The methodology used was very simple but informative and throughout the course there were check points which were very useful and timely.” Amir Dawe / Bard Pharmaceuticals, UK
  • “It has enhanced my understanding of pharmaceutical quality systems, the importance of senior management support and commitment, and having an efficient, well-established PQS to ensure compliance and drive continuous improvement.” Adriana Costa / Mundipharma, UK.
  • “It is really obvious that the team have spent a lot of time working on the delivery of the training. Whatever you have done, keep doing it. The course feels engaged and renewed. The trainers all have a lot of dynamism and enthusiasm.” Lorna Watson / Cancer Research 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 four-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!

Reigster

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 PQS. 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 PQS 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 PQS

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

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:

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 Notman has over 20 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.

Other Dates and Venues for this Course

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

Course Fees

Course cost (excluding VAT)  £2,870.00

DISCOUNTS AVAILABLE

Multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities – 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