Event type:
1 day, professional development training course

Recommended for:

Auditors, scientists and managers
Knowledge of the tutors was excellent. Nice interchange of topics and the inclusion of the MHRA in the course gave a good insight into expectations of the regulators.
Julie Giblin, Assistant Director, QA at Fisher Clinical Services 
James Muller, Qualified Person, Pfizer Global R&D

course programme and information

Course information:

This course is intended for those contributing to quality in the manufacture, testing, distribution and use of investigational medicinal products and will build on your knowledge of the principles and interpretation of current Good Manufacturing Practice.
The course has been designed to meet the needs of:
  • GMP and GCP quality assurance personnel
  • Current and aspiring Qualified Persons
  • Operational personnel in pharmaceutical operations
  • - Manufacturing
  • - Packaging
  • - Laboratories
  • Operational personnel in the clinical environment including
  • - Clinical Research Associates
  • - Hospital Pharmacists
By the end of the course delegates will have:
  • a clear understanding of the history and current status of Good Manufacturing Practice and its application to the manufacture, testing and distribution of investigational medicinal products
  • an understanding of the variety of clinical trial designs and their impact on the investigational product manufacturing process
  • investigated the interface between Good Manufacturing and Good Clinical Practice
  • an understanding of the roles and responsibilities of the Qualified Person and Quality Assurance
  • gained an insight into the activities of the United Kingdom Medicines and Healthcare Products Regulatory Agency and other regulatory agencies

​This course is structured to encourage delegates to:
  • discuss and develop ideas
  • solve specific problems
  • examine particular aspects of Good Manufacturing Practice