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Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING

RQA CPD Stamp

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

Course Information

This two-and-a-half-day course offers the ideal training opportunity for moving into the field of auditing clinical studies.  The course will be of value to those familiar with Good Clinical Practice (GCP), but aiming to apply the principles to auditing; and for those who have audited in other disciplines but are new to GCP. The first afternoon of the course provides an introduction to Good Clinical Practice. The remaining two days concentrate on the practicalities of clinical trial auditing. Workshops give the delegates practical experience of using auditing techniques in a GCP context.  All of the tutors are seasoned auditors who relate theory to their own experiences.

By the end of the course delegates will have

  • a clear understanding of the history and aims of Good Clinical Practice and up-to-the-minute developments
  • a sound regulatory basis for quality assurance activities
  • an idea of what can go wrong with clinical trials and how the auditor can help
  • an understanding of the roles and responsibilities of the clinical trials auditor
  • explored a range of techniques for audit, with examples of helpful documents
  • gained an insight into the activities of the regulatory inspectors
  • developed networking contacts to further their auditing career

Benefits include

  • a clear understanding of the role of the auditor under Good Clinical Practice improved audits
  • improved Good Clinical Practice compliance for your clinical trials

This course is structured to encourage delegates to

  • discuss and develop ideas
  • solve specific problems
  • examine particular aspects of Good Clinical Practice

Course Tutors

Tutors will be comprised from the list below:

Paul Strickland
Managing Director, Strickland Quality Assurance Ltd (Course Principal)

Susana Tavares
Head of Research Quality Assurance, BIAL-Portela & Companhia SA

Cathy Dove
Director and Owner, Dove Quality Solutions

Rosemarie Corrigan
Chief Quality Officer, Nordic Nanovector

Glene Sandom
Executive Director, GxP Corporate Audit EMEA, Celgene Europe Limited

Recent Feedback

"This course provided me with theoretical and practical basis for efficient and successful auditing. Tutors shared with us also practical experiences and this made course more attractive. Workshops gave us possibilities for deep discussions about topics- tutor was present during worshop in virtual classroom and navigated us to keep right direction. I´m grateful that I was a part of this learning activity. I warmly recommend it."

CPD Points

17 Points

Course Programme 

 

Day 1

9.30 Welcome and Objectives for the first day of the course
 9.50 Laying the Foundations
Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 
 11.00 Break
 11.20 Today's Regulatory Framework
A brief review of the regulations and guidelines that describe Good Clinical Practice.
 12.30 Lunch 
 13.30 Patient Protection
Requirements for informed consent and ethics committee .
Access to source documentation.
Including a patient protection exercise.
15.40 Break
16.00 Effective Site Audits
The procedures involved in selecting and setting up audits at investigator sites.
16.45 Introduction to Workshops/end of day Q&A
17.15 Close of day
 

Day 2 

 9.00 Workshop 1 - Planning the Effective Audit
 10.00 Source Data Verification
The need for and purpose of verifying data. 
 10.40 Break 
11.00 Workshop 2 - Source Data Verification
12.10 Workshop 2 - Feedback
12.40 Lunch
 13.40 IMP Management
The requirements surrounding the distribution of investigational medicinal products.
Accountability from release to destruction. 
 14.40 Critical Document Audits
The conduct of other study specific audits including protocols, databases and reports.
 15.35 Break 
 15.55 Non-compliance 
Determining the acceptability of Data 
17.05 End of day Q&A
 17.20 Close of day 
 

 Day 3

 9.00 Auditing Third Parties
A review of audits of contract research organisations. 
 10.10 System Audits
The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 
10.55 Break
 11.10 Workshop 3 - Process Mapping 
 11.50 Effective Audits
Where theory meets reality. 
 12.30 Lunch 
 13.20 Audit Reports - Closing the Loop
An examination of the processes which follow the evidence gathering phase of the audit. 
 14.05 Workshop 4 - Audit Reports
Audit reports, corrective and preventive action. 
14.55 Break
 15.10 Regulatory Inspection
Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 
 16.20 Fraud - Fact or Fiction? 
 17.20 Final Q&A
17.30 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

A Monitor’s Guide to Investigator Site Audits
Good Clinical Practice Regulatory Authority Inspections
Investigators' Guide to Investigator Site Audits
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

P02 Good Clinical Practice Auditing - Principles and Practice
P08 The Auditing Course
P10 Implementing Good Clinical Laboratory Practice
P21 Audit Programmes and Risk Assessment
P32 Process Mapping and SOP Writing
P34 Practical Approach to Auditing Systems and Processes
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting
RP09 The REMOTE Auditing Course
RP10 Implementing Good Clinical Laboratory Practice REMOTE LEARNING
RP14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment REMOTE LEARNING
RP21 Audit Programmes and Risk Assessment REMOTE LEARNING
RP32 Process Mapping and SOP Writing REMOTE LEARNING
RP34 Practical Approach to Auditing Systems and Processes REMOTE LEARNING

eLearning Products

Introduction to Good Clinical Practice (GCP) elearning
Introduction to UK Clinical Trial Regulations elearning
Introduction to the Audit Process elearning

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