Early Bird Pricing Now Available - Book Now.
More informationJoin the community - networking, discussion and more. Open to all.
More informationCould you write an interesting article for the RQA community?
More informationDo you work in Clinical Operations or get involved in Regulatory Agency GCP Inspections?
Do you know what to prepare and get ready for the inspection?
If you answered yes to the first question and no to the second then this course is a must for you….
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
Monjit Summy
Director, Saffron Pharma Consulting Ltd (Course Principal)
Anita Hawkins
Director, GSK
Dounia Sbai
Sr. Director Global R&D QA Deputy GRDQ Head, Ipsen
"Huge experience nicely shared with the participants."
"She gave some great tips and advice after each topic presentation and discussion and throughout the training"
"She provided some great talks on global inspections and about valuable tips from conducting inspections during the COVID-19 pandemic"
Please note this course will run in UK timezone.
Day 1 |
|
9.00 | Introduction and Objectives |
9.30 | Introduction to Inspections |
10.00 | Storyboards – armour in your inspection readiness toolkit |
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 day |
Day 2 |
|
9.00 | Recap from Day 1 |
9.300 | Mock Inspections vs Inspection Preparation – what’s the right approach? |
11.00 | Break |
11.15 | Covid 19 – Your Challenges |
12.15 | Summing Up |
12.30 | 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.
Please note this course will run in UK timezone.
You will need a stable internet connection, a microphone and a webcam.
CAPA: Effective Approaches to Improvement
Management of the Training and Competency of Personnel in GxP and Research Environments
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
RP22 Risk Management in Clinical Trials REMOTE LEARNING
RP34 Practical Approach to Auditing Systems and Processes REMOTE LEARNING