QP Module 12: The Role & Professional Duties of the Qualified Person

About this course

The principal objective of this course is to emphasise how the QP should conduct themselves in discharging their legal duties.

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, therefore, delegates will have the opportunity to test their skills via interactive ‘release or reject’ scenarios.

The role and duties of the QP are constantly being added to and it is essential that QPs keep up-to-date with these new expectations. This course covers these new challenges in detail to help you understand them and their impact.

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

How This Training Will Benefit You

The Aspiring Qualified Person

• This series of 12 modules held over a 21 month period has been carefully designed to meet the requirements for theoretical training detailed in the latest UK Qualified Person Study Guide and EC Directives 2001/82/EC and 2001/83/EC.
• All our training courses provide practical, face-to-face tuition in sufficient depth to prepare you fully for the challenges that lie ahead.
• 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.
• Increasingly, companies are using these modules as part of a modular technical and professional development plan for their staff.
• Additionally, many industry professionals attend the courses as part of their Continuing Professional Development.
• This course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications depending on modules taken and work commitment by students. For further details, please contact Stella Pearson-Smith, our QP Course Administrator at [email protected] for more information.

Course outline

The detailed legal and professional duties of the QP

• What can and cannot be delegated to others

The QP Code of Practice

• Implications for the QP

Current challenges facing the QP

• Proposed and recently implemented

EU legislation and its implications

The role of the QP in complex manufacturing scenarios

• Annex 16 and beyond!

How to be an effective QP

• Influencing skills
• Assertiveness
• Leadership
• Conflict management
• Coaching

The course also includes the vital non-technical skills that a QP needs in order to be able to fulfil their responsibilities.

Links with other functional groups

• The regulatory authorities and the inspectors

Product certification/release criteria

• The decision making process
• To certify or not to certify?

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

The future role of QPs

• The likely impact of ICH Q8, 9 and 10 on the QP

Discussion and Working Groups

A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Venue

Hilton York Hotel, York, UK

The Hilton York Hotel is conveniently located in the city centre and
boasts 130 high-quality rooms, two popular restaurants and secure
parking. The historic city of York has many attractions for visitors;
the famous Minster, many museums, the Jorvik Viking Centre and
excellent shopping. London is two hours away by train and there
is a direct rail link to Manchester Airport. Leeds/Bradford Airport is
also nearby.

Hotel Accommodation

• We have a block booking of bedrooms at the Hilton York Hotel, at
  a specially negotiated bed and breakfast rate per delegate per night.
• As part of our improvements to the booking process, we have arranged for an online booking service with the hotel and details of how to make your accommodation booking will be included in your course joining instructions (issued to you at the time of booking). Alternatively you will be able to make a telephone booking directly with the hotel. If you need any help or guidance with the accommodation booking process, please contact our course administration team.
• Your account with the hotel should be settled at check out.
• Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• 

  Mr Martin Lush
  Senior Partner
  CBiol, MSB, PGDip, FIBMS

  • [email protected]
  • +44(0)1751 432999
• 

  Mr Peter Gough
  Partner
  MSc, CSci, CChem, FRSC, FCQI, CQP

  • [email protected]
  • +44(0)1751 432999
• 

  Mrs Erika Notman
  Consultant
  BSc, MBA, CBiol FSB, MRSPH

  • [email protected]
  • +44(0)1751 432999

What you've said

“Will definitely recommend course to future QP colleagues as I gained lots of useful information and tips to bring ‘back home’. It was good to network and have discussions with other QPs.”

Irene van Amsterdam, GE Healthcare, The Netherlands

“The lecturers, their knowledge of the material and their obvious influence on the industry was really of benefit to me; much more than simply covering the content without the experience.”

Ian Birch, Roche Products, UK

“I gained a detailed knowledge of QP duties and responsibilities re regulation and real life.”

Agnes Eude-Goethals, Baxter Bioscience Manufacturing, Switzerland

“The ‘soft’ skills day was brilliant and very helpful. Strongly suggest that NSF- DBA continue with this approach.”

Lana Morrison, Penn Pharmaceutical Services, UK

“Understanding the legal/duties and having the tools to influence/lead others into compliance.”

Abdul Ghafoor, Bells Healthcare, UK

“The course gives a very good idea of what it’s like being a QP and becoming a QP, and where the pitfalls are. The ‘soft-skills’ day was very useful. Although it just gives you an idea, it has tempted me to look at it in more depth.”

Leen van de Water, Pannoc, Belgium

“Good course. Really enjoyed soft skills.”

Karin van Elburg, Teva Pharmachemie, The Netherlands

“An excellent course giving a thorough basis for understanding the requirements for a QP. The ‘mock viva’ was especially interesting and helped to demystify this potential challenge.”

Malcolm Mellor, Baxter Healthcare, UK

“Excellent presentations and workshop/teamwork. Excellent, well balanced course, very thought provoking.”

Jayne Nicholas, Bristol-Myers Squibb Pharmaceuticals, UK