Jump to content

Good Clinical Practice Auditing - Principles and Practice

CPD Accredited

Book now

Click below for Course dates/fees:

Remote Course Face-to-face Course

Course Information

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?

  • A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments
  • 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:

  • 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.

Tutors

Tutors will be comprised of (click the photos for biographies):

Rosemarie Corrigan

Rosemarie Corrigan

EVP Global Quality, Worldwide Clinical Trials

View pop up

Rosemarie Corrigan

Rosemarie holds the position of EVP Global Quality at Worldwide Clinical trials where she directs and oversee quality and compliance programs for all areas of the Worldwide organization encompassing QMS, quality risk management, audit, training, standards and controlled documents, data integrity, audit and inspection readiness, process improvement, and quality metrics. Previously Rosemarie was the Chief Quality Officer at Nordic Nanovector, where she established the QA strategy and operations for development of radiopharmaceutical products.

Rosemarie holds a Masters in Bioethics and Medical Law from St Mary's University, London, and a Batchelor of Science in Biochemistry from University College Galway. She is eligible to be an QP for IMPs. She is a Fellow of Research Quality Assurance and Fellow of Royal Society of Biology. She is the current chair of RQA GCP committee.

LinkedIn Profile

Cathy Dove

Cathy Dove

Director and Owner, Dove Quality Solutions

View pop up

Cathy Dove

Cathy Dove is a Quality & Risk Management Industry expert, providing risk and quality management consultancy along with GCP audits and bespoke training to a range of Pharma and Biotech clients. She is an RQA GCP Committee member and member of the EFGCP Quality Working Group, working within Clinical Quality Compliance and Risk Management.

Cathy has over 30 years Global Pharmaceutical Clinical Research expertise (Phase I-IV) both from Pharma and CRO and is also a pharmacist. During her career, Cathy has held various global senior leadership positions (including 2 years based in Singapore). Her responsibilities included project quality management, internal audits across all Clinical Research Services, preparation, hosting, and follow-up of inspections from all major regulatory inspectorates and sponsor audits.

As an independent consultant Cathy continues to support clients with inspection readiness, risk and quality management projects, sponsor oversight and vendor audits, complex system and for cause site audits and bespoke training courses.

Cathy has been a course tutor for the RQA GCP Auditing Course for over 20 years and is the course principle for the Risk Management in Clinical Trials course.

Julie Kelly

Julie Kelly

Associate Director, Clinical Quality Assurance, Corcept Therapeutics

View pop up

Julie Kelly

Susana Tavares

Susana Tavares

Director of Research Quality Assurance, -

View pop up

Susana 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.

LinkedIn Profile

Programme

Please note timings may be subject to alteration.

Day 1

12:30

Registration

13:00

Welcome and Objectives for the first day of the course

13:30

Laying the Foundations

Introduction to the clinical development process, the concepts of quality assurance, quality control and audit.

14:30

Break

15:00

Patient Protection

Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise.

16:05

Workshop 1 - Case Study on Informed Consent

16:45

End of Day Questions and Answers

17:00

Close of Day

Day 2

08:50

Questions and Answers from Day 1

09:00

Effective Site Audits

The procedures involved in selecting and setting up audits at investigator sites.

09:40

Workshop 1 - Planning the Effective Audit

10:30

Break

10:45

Source Data Verification

The need for and purpose of verifying data.

11:25

Workshop 2 - Source Data Verification

12:30

Lunch

13:30

IMP Management

The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction.

14:15

Critical Document Audits

The conduct of other study specific audits including protocols, databases and reports.

15:00

Break

15:15

Non-compliance

Determining the acceptability of data.

16:00

Fraud - Fact or Fiction?

How to identify fraud and its consequences

16:45

End of Day Questions and Answers

17:00

Close of Day

Day 3

08:50

Questions and Answers from Days 1 and 2

09:00

Auditing Third Parties

A review of audits of contract research organisations.

10:00

System Audits

The concept of auditing processes across many clinical trials, including a practical exercise in process mapping.

10:45

Break

11:00

Workshop 3 - Process Mapping

11:45

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.

14:20

Workshop 4 - Audit Reports

Audit reports, corrective and preventive action.

15:00

Break

15:10

Regulatory Inspection

Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection.

15:55

Final Questions and Answers

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

  • Very good presentation style, explained easily but with great detail, planned exercises well. Knew the area in the course was for and could therefore share an insight into all questions.

  • Had a good knowledge of the area, excellent exercise facilitation. Easily understandable but gave great detail in her presentations.

  • There was a great group of delegates and I think of all the training I have attended these are the guys I interacted with the most, everyone had a different story to tell, different experience and backgrounds, lots of new contacts added on LinkedIn and lots of people I hope to meet again.

Book now

Click below for Course dates/fees:

Remote Course Face-to-face Course
Back to list
Virtual Event Platform