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About us
Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment
Course Information
- Do 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.
What will I learn?
- A clear understanding of the regulatory inspection process
- Practical experience of preparing for and hosting inspections
- Understanding of current inspection focus topics.
By the end of the course you will be able to:
Provide the necessary skills and tools to prepare and host GCP regulatory agency inspections
Is this course for you?
- GCP quality assurance leaders and managers,
- Clinical research leaders and managers.
Tutors
Tutors will be comprised of (click the photos for biographies):
Anita Hawkins
34 years within the Pharma/Biopharma industry with 26 years experience in Quality Assurance and Compliance. Currently responsible for a global team managing internal significant issue investigations, serious breach notifications and regulatory inspections for both Sponsor and clinical site inspections, operating a flexible working model, to support the needs of each inspection.
Monjit Summy
Dounia Sbai
Programme
Please note timings may be subject to alteration.
Day 1
09:00
Introduction and Objectives
09:30
Introduction to Inspections
10:00
Storyboards - armour in your inspection readiness toolkit
to include a workshop
11:00
Break
11:15
TMF Challenges
12:15
Lunch
13:00
Global and Regional Inspections (FDA, EMA, NMPA (China) and PMDA (Japan)
13:45
Mock Inspections vs Inspection Preparation - What's the Right Approach?
14:30
Break
14:45
Mock Interview - Workshop
15:30
Questions and Answers
16:15
Summing Up
16:30
Close of Day
Day 2
09:00
Recap of Day 1
09:30
Remote and Hybrid Inspection - management
10:00
CRO Oversight - CRO and Sponsor - One Team?
11:00
Break
11:15
Geo-political Impact on Clinical Trials Specific Situations Out of Control e.g. war, pandemic, climate changes, floods etc. - Your Challenges
12:15
Summing Up
12:30
Close of Course
Extra Information
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.
Please note this course will run in UK timezone.
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.
Development Level
Develop
Recommended Products
CAPA: Effective approaches to improvement eBooklet
Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet