Good Clinical Practice Training
About This Course
This is your chance to ask all those questions you wish you could ask during a Good Clinical Practice (GCP) inspection. NSF’s GCP training course is a workshop with presentations, group discussions and case examples.
The aim of this interactive one-day workshop is to provide an introduction to key aspects of GCP. It supports understanding of gap analysis and root cause analysis from Good Manufacturing Practice (GMP)/GCP interfaces.
Key Learning Objectives
By the end of this GCP training workshop, you will:
- Be able to outline the key principles of GCP and reference 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, GCP reference safety information and current GCP inspection findings
Who Should Attend
- Affiliate/country quality assurance (QA) staff and clinical trials staff
- GMP experts, auditors, QPs, and quality control and technical specialists
- GCP and GMP managers wishing to gain an understanding of this GXP interface and current regulatory hot topics