Course Overview

Your chance to ask all those questions you wish you could ask the Inspector when they’ve finished with you! A face-to-face workshop with presentations, group discussions and case examples.

Why You Should Attend

Good Clinical Practice and Good Manufacturing Practice Interface 

The aim of this interactive one day workshop is to provide an introduction to key aspects of Good Clinical Practice (GCP), to support understanding, gap analyses and root cause analyses at GMP/GCP interfaces.

By The End Of This Workshop You Will…

  • Be able to outline the key principles of GCP and reference to current and pending legislation
  • Be able to define and evaluate key differences between GCP and GMP pharmaceutical quality systems
  • Have an awareness of, and have received information on, hot topics including electronic records, data integrity and GCP reference safety information and current GCP inspection findings

Who Would Benefit

  • Affiliate/country QA staff and clinical trials staff
  • GMP experts; auditors, QPs, quality control and technical specialists
  • GCP and GMP managers wishing to gain an understanding of this GXP Interface and current regulatory hot topics

Facilitated By

Louise Mawer is a GXP consultant, auditor and trainer. Working in the fields of GCP, GLP and GVP Louise brings color and enthusiasm to quality assurance. A former MHRA GCP and GLP Inspector, Louise has spent many years in quality assurance and remains highly motivated in these topics. 

Workshop Fees

Course cost (excluding VAT)  £695.00

DISCOUNTS AVAILABLE

Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities - contact us for details.

Have a question or want to book a place? Contact pharmacourses@nsf.org - you can register online by clicking below. You may also be interested in the Good Pharmacovigilance Practice workshop taking place the day after. 

Register