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About us
Good Clinical Practice Auditing - Principles and Practice
Course Information
The GCP Auditing - Principles and Practice courses scheduled from March 2025 will include updates from the ICH E6R3 guidance for consideration during audit planning, conduct and management in readiness for when the ICH GCP E6R3 Guidance becomes effective.
Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines.
How is this course run?
Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys.
What will I learn?
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A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments
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Solid grounding in quality assurance activities aligned with regulatory standards
- Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues
- Clarity on the roles and responsibilities inherent to clinical trials auditing
- Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents
- A nuanced understanding of regulatory inspectors' activities
- Expanded professional networks to propel your auditing career forward.
Benefits include:
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A clear understanding of the role of the auditor under Good Clinical Practice improved audits
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Improved Good Clinical Practice compliance for your clinical trials.
This course is structured to encourage delegates to:
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Discuss and develop ideas
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Solve specific problems
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Examine particular aspects of Good Clinical Practice.
Tutors
Tutors will be comprised of (click the photos for biographies):
Julie Kelly
Susana Tavares
Director of Research Quality Assurance, Stavares Consulting Unipessoal Lda
View pop upSusana Tavares
Experienced Director of Research Quality Assurance with a demonstrated history of working in the pharmaceuticals industry. Strong skills as a manager and in Auditing CROs, partners, sites, systems, documental audits along several regions in preclinical, clinical and pharmacovigilance field. Also high experienced as a trainer and in quality systems among Good Clinical Practice (GCP), Good Preclinical Practices (GLP), Pharmacovigilance, Medical Affairs and corporate quality systems. Hosted a high number of FDA, EMA, Infarmed inspection for GCP, GLP and pharmacovigilance.
Shaun is an experienced Quality professional, with over two decades working in quality at Pharma, CROs and Investigator Site covering all aspects of quality including SOPs, Training, Audits including internal and service providers, inspection readiness and hosting, process improvement and quality metrics.
Shaun has over 10 years of experience auditing in the UK and abroad, including investigator sites, and service providers including CROs, Data Management and Statistics providers, Laboratories, Phase 1 units, IMP management and storage and QP providers, Equipment servicing/calibration, Couriers, Records Management/Archiving providers, eQMS providers, IT operations providers, E-Signature solutions and Specialist Consultants (e.g. Medical Monitoring).
Shaun holds a Masters in Quality Management in Scientific Research and Development from Cranfield University and is a member of the RQA GCP Committee.
Piran Sucindran is the Head of Quality at Blue Earth Therapeutics, where he applies his extensive background in biotechs, imaging contract research organisations, and NHS investigator sites. With significant experience in both Good Clinical Practice (GCP) and radiopharmaceutical Good Manufacturing Practice (GMP), he has led global GxP quality teams, including those focused on auditing and operational quality.
Since 2018, Piran has been a member of the RQA GCP Committee. His key areas of expertise include data governance, oversight of computerised systems, and ensuring the scalability of quality systems to meet evolving business needs.
Programme
Please note timings may be subject to alteration.
Day 1
11:30
Registration
12:00
Welcome and Objectives for the first day of the course
12:45
Laying the Foundations including Today's Regulatory Framework
Introduction to the clinical development process. The concepts of quality assurance, quality control and audit. A brief review of the regulations and guidelines that describe Good Clinical Practice.
13:45
Break
14:15
Patient Protection
Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise.
15:20
Workshop 1 - Case Study on Informed Consent
15:55
Workshop 1 - feedback
16:05
Foundations of GCP Auditing
Essentials for planning and conduct of GCP audits.
16:50
End of Day Q&A
17:00
Close of Day
Day 2
08:50
Q&A from Day 1
09:00
Investigator Site Audits
The procedures involved in selecting and setting up audits at investigator sites.
09:40
Workshop 2 - Planning the Effective Audit followed by feedback
10:20
Break
10:40
Source Data and Audit
The need for and purpose of verifying data.
11:20
Workshop 3 - Source Data Verification followed by feedback
12:40
Lunch
13:40
IMP Management
The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction.
14:25
Critical Document Audits
The conduct of other study specific audits including protocols, Informed Consent Forms, CSRs, IBs and reports. Examples to be included.
15:25
Break
15:45
Non-compliance
Determining the acceptability of data.
16:45
Fraud - Fact or Fiction?
How to identify fraud and its consequences
17:15
Q&A from Day 2
17:30
Close of Day
Day 3
08:50
Q&A from Days 1 and 2
09:00
System Audits
09:45
Workshop 4 - Process Mapping
The concept of auditing processes across many clinical trials, including a practical exercise in process mapping.
10:15
Workshop 4 - feedback
10:35
Break
11:00
Auditing Service Providers
A review of contract research organisations audits.
12:00
Lunch
13:00
Audit Reports - Closing the Loop
An examination of the processes which follow the evidence gathering phase of the audit. Include response, CAPA and effectiveness checks, audit certs.
14:10
Workshop 5 - Audit Reports
Audit report and how to construct an audit observation.
14:50
Break
15:10
Regulatory Inspection - readiness and hosting
Auditors and regulatory inspections - how the QA team can help the organisation to perform during a regulatory inspection.
15:55
Final Q&A
16:10
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.
Course Material
Course material will be available 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.
CPD Points
17 Points
Development Level
Learn
Recommended Products
A Monitors Guide to Investigator Site Audits eBooklet
CAPA: Effective approaches to improvement eBooklet
Good Clinical Practice Regulatory Authority Inspections eBooklet
Introduction to Good Clinical Practice (GCP) elearning
Introduction to the Audit Process elearning
Investigators' Guide to Investigator Site Audits eBooklet
Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet
Webcast - The Biggest Change to International GCP
Webcast - Where Does Audit End?