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Good People Working on Good Projects with Good Process

Good Clinical Practice (GCP)

November 14, 2019 (4 hrs) $325.00 Agenda (Central Time)

 

Course Description

This Frestedt Learning Center course is a 4-hour session (8:30-12:30 CST) offered by the Frestedt Inc. team. We will review Good Clinical Practices (GCPs) such as US FDA Good Clinical Practice Regulations, ICH E6 (R2) Good Clinical Practice Guidelines and ISO14155:2011 Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice Standards. The team will discuss other topics such as HIPAA and Research in Children. The course will be interactive and will provide resources which can be applied to practices in research. Our goal is to engage the audience in a discussion of GCPs and ethical considerations for clinical trial conduct in human research. The course is available in person at the Frestedt Inc. office (limited seating) as well as online (unlimited).

Benefits to Your Business

  • Stay updated with GCP regulations to assure your studies are in compliance with latest regulations
  • Engage in activities applied to GCP

Learning Objectives

On completion of this training, participants will be able to:

  • Define GDP, GMP and discuss GCP history and goals
  • List US FDA GCP regulations
  • Describe ICH E6 GCP guideline
  • Use ISO 14155 GCP standard
  • Comply with GCP requirements every day!

Intended Audience

  • Scientists conducting human research in industry or hospital settings.
  • Candidates looking to transition into a clinical career

Agenda (Central Time)

8:00am-8:30am

Arrival and Check-in

8:30am-8:45am

Introduction

8:45am-10:30am

GCP and GCP Framework

10:30am-10:45am

Mid-morning break

10:45am-12:00pm

GCP Details and HIPPA & Research in Children

12:15pm-12:30pm

Wrap-up and Q&A

To book this course or set up a custom training, call 952-426-1747 or email info@frestedt.com.