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The Role and Professional Duties of the QP Course

Dates

Times

3 days

Location

In-Person - York, United Kingdom

Availability

Dates

Times

4 days16 hrs VILT, 5 hrs self-paced

Location

Virtual Learning

Availability

Dates

Times

3 days

Location

In-Person - York, United Kingdom

Availability

About This Course

This intensive, interactive 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.

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 offered either virtually, or in-person in York. If you choose our virtual learning option, training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. Full details will be sent to you following registration.

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 and the Code of Practice of the QP
  • 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
  • Update on proposed and recently implemented legislation and guidance
  • The interpersonal skills essential to be a good QP

Course Outline

Detailed QP Legal and Professional Duties

  • Detailed review of Annex 16
  • Import scenarios

Batch Certification/Release Criteria

  • The risk-based decision making process
  • PQS and QP oversight
  • Shaping human performance factors to set teams up for success

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.

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 years’ industrial experience and is a practicing QP working for several leading companies. She now acts as a consultant and contract QP.

Vicky Baulch – Vicky has more than 20 years’ experience within the pharmaceutical industry, with expertise in API manufacturing, Clinical trial manufacture and packaging, non sterile and sterile product manufacture and is a practicing QP.

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, where she was responsible for the start-up of a new solid dose manufacturing and packaging facility.

Discounts

Multi-delegate discounts available. Discounts also offered to NHS staff and charities.

  • I learnt a lot more from the leadership elements than I expected, thanks! All elements of the course were excellent.
    Janet Downie
    RoslinCT, UK
  • Has provided a much better and more detailed understanding of the role of the QP and good detail on the legal requirements.
    Matthew Rowlands
    RB, UK
  • Very good balance between theory and practice.
    Stefania Marveggio
    GSK Vaccines, Switzerland

Additional Recommended Courses

Pharmaceutical Quality Systems
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Analysis and Testing

This highly focused, intensive four-and-a-half-day course, taught by leading scientists and former Quality Control Managers, is designed to provide the aspiring Qualified Person or pharmaceutical quality professional with the knowledge and understanding they need to be able to perform their duties with skill and competence when interacting with the Quality Control laboratories.

We will explain to you the strengths and limitations of analysis and specific analytical methods, we will advise you on how to apply the principles of quality management and GMP to the testing environment in a pragmatic, effective way, and we will advise you of the very latest “hot topics” with the regulators and how to ensure that your laboratories are in compliance.

This virtual blended training course will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. This will require an element of learning to be completed prior to the virtual classroom, as well as afterwards and this will be managed through our online Learning Management System. Full details, including timings for the instructor-led virtual classrooms, will be emailed following registration.

Tutors: Dave Waddington, Oona McPolin

Price: £3555 excluding VAT (where applicable)

Course registrations will close 5 working days before the start of the course.

You can view our booking terms and conditions from here.

Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff are entitled to a 50% discount. (Proof will be required).

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