About This Course

This intensive, interactive four-day training course provides aspiring QPs and other pharmaceutical quality professionals the knowledge and understanding they need to perform the legal duties of the QP. Further, it teaches attendees 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 also helps you to understand what the QP must do themselves and what can/must be delegated to others. We provide advice on how the QP should work in tandem with professionals in other departments and stress the non-technical people skills that are essential to be a good QP.

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

When certifying medicinal products, it is of paramount importance that a QP has the ability to look at the broad issues of managing quality and to approach these issues in a cohesive way when making decisions to release or reject. Throughout the course you’ll have the opportunity to test your skills via interactive release or reject scenarios.

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

Key Learning Objectives

On completion of this course, delegates will know and understand:

  • The QP’s legal and professional duties in detail
  • 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
  • The non-technical people skills essential to be a good QP

Course Outline

Detailed QP Legal and Professional Duties

  • 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

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 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:

Peter Gough - Peter has nearly 45 years’ pharmaceutical industry experience, with over 20 years as a practicing QP. He is also 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.

Richard Giles - Richard is an expert in achieving a shift of attitude or performance in individuals or teams, in leadership development and in managing conflict.

Samantha Clack - Samantha has 20 year’s industrial experience and has been a practicing QP for more than half that time, working for several leading companies. She now acts as a consultant and contract QP.

Discounts

Early bird and multi-delegate discounts available. Discounts also offered to NHS staff, regulators and charities.

Early bird discounts cannot be used in conjunction with multi-delegate discounts.