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
This course is structured to encourage delegates to
Tutors will be comprised from the list below:
Managing Director, Strickland Quality Assurance Ltd (Course Principal)
Head of Research Quality Assurance, BIAL-Portela & Companhia SA
Director and Owner, Dove Quality Solutions
Chief Quality Officer, Nordic Nanovector
Executive Director, GxP Corporate Audit EMEA, Celgene Europe Limited
"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."
|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.
|11.20||Today's Regulatory Framework
A brief review of the regulations and guidelines that describe Good Clinical Practice.
Requirements for informed consent and ethics committee .
Access to source documentation.
Including a patient protection exercise.
|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|
|9.00||Workshop 1 - Planning the Effective Audit|
|10.00||Source Data Verification
The need for and purpose of verifying data.
|11.00||Workshop 2 - Source Data Verification|
|12.10||Workshop 2 - Feedback|
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.
Determining the acceptability of Data
|17.05||End of day Q&A|
|17.20||Close of day|
|9.00||Auditing Third Parties
A review of audits of contract research organisations.
The concept of auditing processes across many clinical trials, including a practical exercise in process mapping.
|11.10||Workshop 3 - Process Mapping|
Where theory meets reality.
|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.
Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection.
|16.20||Fraud - Fact or Fiction?|
|17.30||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.
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
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