Course Overview

  • “Very enjoyable course, great lecturers. Good mix of regulations and soft skills.” Alana Kennedy / Actavis, Ireland
  • “Has provided a much better and more detailed understanding of the role of the QP and good detail on the legal requirements.” Matthew Rowlands / Reckitt Benckiser, UK
  • “Very good balance between theory and practice.” Stefania Marveggio / GSK Vaccines, Switzerland

FULLY SUBSCRIBED: This intensive, interactive 4 day training course is designed to provide aspiring QPs and other pharmaceutical quality professionals with the knowledge and understanding they need of the legal duties of the QP and, more importantly, how the QP must work with others to ensure that those duties and responsibilities are performed in the best interests of the company, the patient and society. This course will help you to understand what the QP must do themselves and what can/must be delegated to others, it will provide advice on how the QP should work in tandem with professionals in other departments, and will stress the non-technical “people” skills that are essential to being a good QP.

About This Course

The role and duties of the QP are constantly changing and the revision of EU GMP Annex 16 introduces some significant new expectations. It is, therefore, essential that QPs keep up to date. This course covers these new challenges in detail to help you understand them and their impact.

Of paramount importance is the ability to focus on the broad issues of managing quality and to bring these issues together in a cohesive way when making decisions to certify medicinal products. Throughout the course you will have the opportunity to test your skills via interactive “release or reject” scenarios.

The course will also include a simulation of a typical UK QP assessment interview as conducted by the three professional bodies.

This course is approved by the Royal Society of Chemistry as suitable for their members’ continuing professional development.

Key Learning Objectives

On completion of this course delegates will know and understand:

  • The QP’s legal and professional duties and have detailed knowledge on these duties
  • How the QP must work with others to ensure that those duties and responsibilities are performed in the best interests of the company, the patient and society
  • What the QP must do themselves and what can/should be delegated to others, how the QP should work in tandem with professionals in other departments, and to stress the non-technical people skills that are essential to being a good QP

Course Outline

Detailed QP Legal and Professional Duties

  • Including a detailed review of Annex 16
  • Import scenarios

Product Certification/Release Criteria

  • The risk-based decision making process
  • To certify or not to certify?
  • Minimizing human error

Role of the QP in Complex Manufacturing Scenarios

  • Release or reject?

Routes to Becoming a QP across the EU and the UK Assessment Procedure

  • Education and training of QPs
  • Simulation of a typical UK QP assessment interview procedure

Links with Other Stakeholders

  • The regulatory authorities and the inspectors
  • Preparing for regulatory authority inspections

How to be an Effective QP

  • Influencing skills and assertiveness
  • Leadership
  • Conflict management and coaching

QP Code of Practice

  • Implications for the QP

Current Challenges Facing the QP

  • Proposed and recently implemented legislation and guidance

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

  • Peter Gough - Peter has over 40 years’ pharmaceutical industry experience, with over 20 years as a practicing QP, and is a former chair of the Royal Society of Chemistry’s QP Assessor panel.
  • Erika Notman - An experienced QP, Erika is a former chair of the Royal Society of Biology’s QP Assessor panel.
  • Catherine Kay - A chemist by training, Catherine has more than 23 years’ experience in pharmaceutical operations management and quality assurance, as well as being eligible to be a QP.  She is keen to ensure that QP’s have the support and skills to lead, influence and add value to their organisation.

Other Dates and Venues for this Course

Visit our course calendar

Course Fees

Course cost (excluding VAT)  £2,750.00

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.

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