The Auditing Course

Description

Designed to develop personal proficiency in audit planning, execution and reporting, this course is meticulously crafted to refine essential audit skill sets. Through immersive scenarios focused on on-site audit conduct (with an alternative Remote Auditing Course available), participants will engage deeply in the audit process.

Applicable across all audit types, this course builds upon and enriches the foundational concepts taught in RQA's suite of research quality assurance courses. From 'Research Quality Assurance for Good Laboratory Practice' to 'Good Clinical Practice Auditing – Principles and Practice' and 'Good Manufacturing Practice for Investigational Medicinal Products,' this programme extends the scope of learning.

Relevant to any area of regulated research and development, this course shines particularly in contexts mandating a quality system for audit. Participants with prior audit experience will gain maximum value from this course. 

Structured to foster dynamic engagement, this course encourages delegates to:

A highlight of this course is the series of practical workshops, where delegates work in small syndicate groups, applying the acquired skills from lectures into real-world scenarios.

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

Founder Director, Tower Mains Ltd

Senior QA Associate, Tower Mains Ltd

Director, The Knowlogy Group Ltd

Associate Director, Alexion

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Please note timings may be subject to alteration.

Registration

Welcome and Course Objectives

What is 'Audit'?

Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements.

Audits and their Purpose

The concepts of quality assurance, quality control, quality management and audit are discussed.

Break

Audit Planning

The requirements for an effective audit programme and individual audit plans.

Workshop 1 - Getting the Audit Started

Planning for the audit.

Workshop 1 - Feedback

Lunch

Workshop 2 - Getting the Audit Started

Arranging the opening meeting.

Workshop 2 - Feedback

Audit initiation. Review and discussion of the role of the opening meeting.

Auditing Techniques (1) - Data and Documentation

Techniques for the conduct of data and report audits are investigated.

Break

Workshop 3 - Data and Documentation Audit

Conducting an audit of a data package and supporting documentation.

Close of Day

Auditing Techniques (2) - The People

Questioning techniques which get the required information from the auditee.

Live Audit Role Play

Auditor and auditee behaviours are explored and strategies developed for successful audit interactions.

Break

Audit Closing Meeting

An exploration of audit closing meetings.

Workshop 4 - Audit Observations and Preparing for the Closing Meeting

Reviewing and categorising your observations and getting ready to present your case.

Workshop 4 - Feedback

Audit Reports

The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed.

Lunch

Workshop 5 - Audit Reports and Follow-up

Mechanisms for promoting effective corrective and preventive action. Critical review of an audit report example.

Workshop 5 - Feedback

Corrective and Preventive Action and Follow-up

The auditor's role in monitoring responses to audit and the corrective and preventive actions promised is explored.

Panel Session

An opportunity to get answers to outstanding questions.

Close of Course

Course material will be available in PDF format for delegates attending this course. The advantages of this include:

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.

14 Points

Develop