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Juin
2018

Investigational Medicinal Products - QP Module

Royaume-Uni, York

11 juin 2018 - 14 juin 2018

Entrée : 2 750,00 £ (HTVA)

Déjeuner: inclus
Multiple delegate discounts available. Discounts also offered to NHS staff, regulators and charities.
Public ciblé: Aspiring qualified person Pharmaceutical technical professional
Ajouter

Course overview :

This four-day course focuses on the quality systems and the GMP/GCP interface from the Qualified Person or quality leader’s perspective. It focuses on the QP’s duties and challenges in protecting trials, volunteers and patients. Led by former IMP expert inspectors, QPs and current consultants, this highly interactive course adds value to QPs, auditors and those working in clinical trial suppl


Benefits :

  • Explains the new regulations and requirements of the QP
  • More than meets the QP study guide requirements for IMPs
  • Essential training for QPs or others involved in clinical trial supply
  • MSc level training with a real industrial perspective
  • Access to tutors with credibility who bring years of knowledge in IMP, MHRA and consulting to explain and answer your own questions
  • Talk to expert tutors to understand what the regulators and inspectors look for
  • A chance to prepare for and improve your next inspection or IMP audit
  • Essential for those auditing IMP operations on behalf of a QP
  • Clearly defines QP duties
  • Explains IMPs and FMD, validation We don’t just train to pass a Viva – we take the time to prepare you to excel. Our detailed educational documentation grows to a lifelong reference library


Discussion and working group :

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, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific question and concerns.



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.

The clinical trial

  • The phases of clinical trials
  • Impact of trial design on manufacturing and packing operations


Regulatory Framework

  • Directives 2001/20/EC and 2005/28/EC
  • Annex 13


Role of the Qualified Person

  • The legal duties
  • Key documentation – the CTA, the IMP dossier and the Product Specification File
  • Control and certification of products manufactured or sourced outside the European Union
  • The two stage release process
  • The role of the QP in split manufacture and in virtual companies
  • The special challenges


Good Manufacturing Practice

  • Sourcing of materials, including comparators
  • Production and quality control of IMPs
  • Packaging issues – blinding and product security
  • Validation – how much, how soon?
  • Assigning and extending shelf life
  • Retains and returns
  • Assessing ‘equivalence’ of GMP standards


Good Clinical Practice

  • What is GCP ?
  • The GMP/GCP interface – when do the responsibilities of the QP end?
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    Darren Jones

    Consultant

    GMP Inspector - Pharmaceutical auditing - Clinical trial

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    Liz Allanson

    Consultant

    Pharmacist - 19 Years as a GMP Inspector with UK MHRA

Suivant

Résumé

Darren Jones has 25 years of experience in pharmaceutical auditing, consulting and regulatory inspection support and preparation. Prior to joining NSF, Mr. Jones worked at MHRA where he spent four years as a GMP inspector. He inspected many sites of varied dosage forms worldwide and developed considerable experience of complex aseptic manufacture and terminal sterilization for both commercial and clinical trial applications.

Earlier in his career, Mr. Jones spent 18 years in a number of roles at AstraZeneca, including production outsourcing, selecting and managing contract manufacturing sites primarily engaged in sterile manufacture.

Mr. Jones has provided QA support to an API facility which included laboratory-scale production for parenteral products, traditional manual plant and modern computer-controlled facilities. He has also provided QA support to tablet processing and packaging activities.

Mr. Jones’ areas of expertise include:

  • GMP auditing of facilities and processes
  • Sterile manufacture
  • Clinical trial manufacture
  • Supply chain excellence
  • Microbiological QC

Liz Allanson is a pharmacist by profession and has a special interest in quality management and leadership skills. She spent almost 19 years as a GMP inspector with the UK MHRA, primarily as one of the senior managers in the MHRA Medicines Inspectorate. Her last position with MHRA was managing the GMP inspection team.

Ms. Allanson is eligible to act as a Qualified Person and is a registered IRCA lead auditor. Her areas of expertise include:

  • EU GMP pharmaceutical legislation and regulatory expectations, including requirements for investigational medicinal products
  • GMP and GDP compliance
  • Quality management systems
  • Clinical trial manufacture/packaging and QP release
  • Auditing and mock regulatory GMP inspections
  • Supply chain management
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