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Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment

Course Information

This course has been designed to provide you with the necessary skills and tools to prepare and host a regulatory inspection and to facilitate the response and follow-up to the inspection findings. 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
  • Techniques for interpreting findings and observations and facilitating the preparation of effective responses
  • Techniques for facilitating correction, corrective and preventive action arising from inspection findings

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

"Very good presentation and good facilitation at the work shop."
"Very good presentation and also good at giving real time examples."

 

Course Programme

Please note timings are subject to alteration

9.30 Introduction and Objectives
9.50 Introduction to Inspections - the basics
10.10 Computerised System Validation and Data Integrity - more than just audit trail review
11.00 Break
11.15 TMF Challenges - you have a 'single eTMF' ... so, what's next?
12.15 Lunch
13.00 Inspection Preparation - proactive or reactive?
13.45 Inspection Management - what's new?
14.30 Break
14.45 Root Cause Analysis, CAPA Development and Effectiveness Checks - why is it so hard to get to the right root cause and how to develop effective Effectiveness Checks?
15.30 Q&A - Panel session with speakers
16.15 Summing Up
16.30 Close of course

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

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

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.

You will also receive a copy of our booklet - "Good Clinical Practice Regulatory Authority Inspections"

Accommodation

Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities). 
If you wish to book additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process.  As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall.  Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.

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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
P34 Practical Approach to Auditing Systems and Processes
RP14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment REMOTE LEARNING

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