About This Course

As a QP or quality assurance auditor in this challenging area, are you aware of the current and planned changes around the manufacture of investigational medicinal products (IMPs)? This highly interactive IMP training course makes sure you are up to date.

Our three-and-a-half-day course focuses on the quality systems and the Good Manufacturing Practice (GMP)/Good Clinical Practice (GCP) interface from the QP or quality leader’s perspective. More specifically, the QP’s duties and challenges in protecting trials, volunteers and patients. Led by former IMP expert inspectors, QPs and current consultants, this course adds value to QPs, auditors and those working in clinical trial supply.

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

Key Learning Objectives

On completion of our IMP training 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 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, Falsified Medicines Directive (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, e.g. the Clinical Trial Authorisation (CTA), IMP dossier and 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
  • 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 portion of course time is devoted to group work. Using case studies, delegates have the opportunity to put theory into practice. In addition, discussion periods (which include 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 the best available and our QPs are held in high regard in 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 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:

Richard Funnell - Richard spent 11 years with the MHRA, including seven as a Senior GMP Inspector with the lead for IMPs. Richard has current knowledge and understanding of what inspectors are looking for in the lead-up to the new clinical trial regulation being implemented.

Darren Jones - Darren is an ex-MHRA GMP Inspector and has audited dosage forms for both commercial and clinical trial applications. Darren also has a wealth of practical knowledge and experience applying GMP in the clinical development world gained during his 18 years with AstraZeneca, prior to joining the MHRA. He was a QP for IMPs and knows the real challenges and how to overcome them.

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

Early bird and multi-delegate discounts available. Discounts also offered to NHS staff, regulators and charities.

Early bird discounts cannot be used in conjunction with multi-delegate discounts.