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Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment REMOTE LEARNING

REMOTE LEARNING - this course will be delivered to you live online from the UK. 

Course Information

This course has been designed to provide you with the necessary skills and tools to navigate the preparation and hosting of GCP regulatory agency inspections in a rapidly changing environment where the way inspections are conducted and the focus of inspection is ever changing. The course encompasses inspections at sponsor and contract research organisation sites, as well as at the investigator site. The course will also look at current inspection finding trends and inspection hot topics/focus trends.

Benefits include

  • A clear understanding of the regulatory inspection process
  • Practical experience of preparing for and hosting inspections
  • Understanding of current inspection focus topics
  • Techniques for developing responses arising from inspection findings inclduing Root Cause Analysis, CAPA Development and Effectiveness Checks

Course Tutors

Tutors will be comprised from the list below

Monjit Summy
Director, Saffron Pharma Consulting Ltd (Course Principal)

Fareha Ring
Manager, Clinical Quality Assurance - Regulatory Inspections & Investigations, GSK

Balall Naeem
Associate Director, IQVIA

Recent Feedback

"Huge experience nicely shared with the participants."
"Nice presentation skills and experience. Very communicative even remotely."

Course Programme 

9.00 Introduction and Objectives
9.30 Introduction to Inspections
10.00 Covid 19 - Your Challenges
11.00 Break
11.15 TMF Challenges 
12.15 Lunch
13.00 Mock Inspection vs Inspection Preparation - what's the right approach?
13.45 Remote Inspection - Here to Stay
14.30 Break
14.45 CRO Oversight - CRO & Sponsor - One Team?
15.30 Q&A
16.15 Summing Up
16.30 Close of course

 

Course Material

This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course 
  • Environmental benefits – less paper being used per course
  • Access to an online course group to enhance networking

You will need a stable internet connection, a microphone and a webcam. 

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Recommended Products

Booklets

CAPA: Effective Approaches to Improvement*
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

P02 Good Clinical Practice Auditing - Principles and Practice
P05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
P08 The Auditing Course
P14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment
P34 Practical Approach to Auditing Systems and Processes
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
RP05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management REMOTE LEARNING
RP09 The Remote Auditing Course REMOTE LEARNING
RP34 Practical Approach to Auditing Systems and Processes REMOTE LEARNING

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