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Juil.
2017

The Role and Professional Duties of the Qualified Person - QP Module

Royaume-Uni, York

Course overview :

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. This course is also RSC Approved.


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 :

  • Provides aspiring QPs and other pharmaceutical quality professionals with the knowledge and understanding they need of the QP’s legal duties
  • Demonstrates 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
  • Will help you to understand what the QP must do themselves and what can/must be delegated to others, 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


Registration link :

  • NSF Online registration : Link

NSF contact :

Note : 

  • All of our courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Course Outline :

Detailed QP Legal and Professional Duties

  • Including a detailed review of the revised Annex 16
  • Import scenarios

QP Code of Practice

  • Implications for the QP


Current Challenges Facing the QP

  • Proposed and recently implemented legislation and guidance


Product Certification/Release Criteria

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


EU Legislation and its Implications

Role of the QP in Complex Manufacturing Scenarios

  • Annex 16 and beyond!


How to be an Effective QP

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


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

Minimizing Human Error

  • John McCool

    Consultant

    PGCE, PGDip, MRSC

  • Peter Gough

    Executive Director

    MSc, CSci, CChem, FRSC, FCQI, CQP

  • Erika Notman

    Consultant

    MBA, CBiol, FSB, MRSPH

Suivant

Résumé

John is a currently active QP who qualified in 2008 and has since worked for a range of companies from small virtual, academic institutions to large multinational companies.

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.

An experienced QP, Erika is a former chair of the Royal Society of Biology’s QP Assessor panel.