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.
Tutors will be comprised from the list below
Director, Saffron Pharma Consulting Ltd (Course Principal)
Manager, Clinical Quality Assurance - Regulatory Inspections & Investigations, GSK
Associate Director, IQVIA
"Huge experience nicely shared with the participants."
"Nice presentation skills and experience. Very communicative even remotely."
|9.00||Introduction and Objectives|
|9.30||Introduction to Inspections|
|10.00||Covid 19 - Your Challenges|
|13.00||Mock Inspection vs Inspection Preparation - what's the right approach?|
|13.45||Remote Inspection - Here to Stay|
|14.45||CRO Oversight - CRO & Sponsor - One Team?|
|16.30||Close of course|
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.
You will need a stable internet connection, a microphone and a webcam.
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