Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
REMOTE LEARNING - this course will be delivered to you live online from the UK.
Course Information
This 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. Delegates are expected to have some knowledge of Good Clinical Practice prior to attending to maximise their learning in learning how to audit against the guidelines. The course 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 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:
Patricia Henley
Head of Research Governance and Integrity, London School of Hygiene and Tropical Medicine (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
"RQA online courses are a brilliant resource. Remotely located RQA members now have a much greater opportunity to learn and participate."
"Made serious subjects fun and interesting at time, very nice presentation style. Very knowledgeable. All presenters very good at facilitating the exercises and providing good feedback."
"Presenters had a good level of knowledge and expertise and this meant sharing lots of valuable experiences in all areas of auditing."
CPD Points
17 Points
Course Programme
Please note this course will run in UK timezone.
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.
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.
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
RP09 The Remote Auditing Course REMOTE LEARNING
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
