Investigational Medicinal Products - QP Module

24 June 2019 08:30 - 27 June 2019 12:00, London, United Kingdom


Introduction
This three-and-a-half-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 supply.

As a QP, QA or auditor in this challenging area, are you aware of the current and planned changes around investigational medicinal products (IMPs)? This course will make sure you’re up to date.

On this highly interactive course you’ll learn from former IMP expert instructors, QPs and current consultants, focusing on quality systems and the GMP/GCP interface from the QP or quality leader’s perspective. We look at the QP’s duties and the challenges presented when it comes to protecting trials, volunteers and patients.

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

Key Learning Objectives

On completion of this course delegates will know and understand:
  • The new regulations and requirements for the QP
  • The subjects required in the IMP element of the QP study guide
  • What the regulators and inspectors look for
  • How to prepare for your next inspection or IMP audit
  • Where to focus audits of IMP operations on behalf of a QP
  • QP duties around IMPs
  • IMPs, FMD and validation

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

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 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.
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.

Find out why you should choose NSF for your QP training by visiting our qualified person training section.
Venue
DoubleTree by Hilton Docklands

DoubleTree by Hilton Docklands, 265 Rotherhithe St, London, SW16 5HW, United Kingdom

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