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Audit Programmes and Risk Assessment

A 10% discount will be available against this course when booked along with a Full Conference Delegate package. To take advantage of this discount, please add all items to your basket and enter PRECON as the discount code at the checkout. 
This can also be booked as a stand alone course.

Course Information

This one day course is designed to provide comprehensive guidance and practical help for those who need to design and implement audit programmes. It uses the guidance of ISO 19011 with reference to PV, GCP, GMP and GLP audit programmes to explore audit programme design, operation, review and improvement.
The course will work through why audits are important and understanding the drivers behind a good audit programme. It will discuss how to identify and assess the risks in your organisation, linking them with organisational goals, using these risks as a basis for the design of a risk based audit programme during facilitated practical workshops. Delegates will have the opportunity to consider and discuss common issues and constraints that may shape their audit programmes.

By the end of the course delegates will have

  • a clear understanding of the role of audit programmes in managing compliance and of the drivers and risks behind audit programmes
  • an understanding of the roles and responsibilities of management and personnel
  • an appreciation of resourcing implications and auditor attributes
  • a good insight into the practicalities and activities required for design of risk based audit programmes
  • a comparison of delegates’ circumstances, challenges, common issues and ways to approach managing audit programmes

Course Tutors

Louise Handy
Director, Handy Consulting Ltd (Course Principal)

Angela Jennings
Director, Quality and Process Improvement, Syne Qua Non Ltd

Recent Feedback

"Liked the possibility and freedom of discussion.
Both [tutors] gave the impression of professionals who know their remit."

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material 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.

Accommodation

Hotel accommodation is not included in the course fees. Accommodation should be booked direct with hotels in Edinburgh. The following link will take you to a number of hotels where special rates have been negotiated. This is a service not run by RQA. http://www.successfuleventslive.co.uk/5th_Global_QA_Conference_2017

Course Programme

Day 1

8.50 Registration
9.00 Welcome and Introduction
9.15 Why do we Need to Audit?
Exploring risk and regulation, responsibility and performance.
Understanding the needs of delegates’ own organisations and comparing common themes and threats
10.00 Establishing an Audit Programme
Design, objectives, risk & resources. This session discusses the theory behind managing audit programmes, and how management should lead the auditing process to ensure practice will meet expectations
10.45 Break
11.00 Workshop 1 – Risk and Design
Practical issues with regard to objectives and resources are explored
11.45 Workshop 1 Feedback
12.00 Lunch
13.00 Putting it into Practice
Responsibilities, practicalities & challenges – the realities of auditing. This session explores management’s responsibilities and input, including selection of auditors and the reasons to note audit results
13.45 Workshop 2 – Managing Programmes and Risks
Looking at audit programmes and managing risks. What sort of a manager are you? How does this affect implementation?
14:45 Break
15.00 Workshop 2 Feedback
15:30 Monitoring, Reviewing and Improving
Why or when should management change existing processes, understanding the implications of change or inaction and exploring how to improve the audit programme
16.15 Panel Session
This final session will address any outstanding issues raised by delegates
16.30 Close of course

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Recommended Products

Booklets

Auditing Computerised Systems Booklet
Guidelines for Quality in Non-Regulated Scientific Research Booklet
Quality in Research Booklet

Courses

C8022 GCP Auditing - Principles and Practice (11th Sep 2017 - 13th Sep 2017 )
C8023 GCP Auditing - Principles and Practice (26th Feb 2018 - 28th Feb 2018 )
C8082 The Auditing Course (30th Oct 2017 - 31st Oct 2017 )
C8083 The Auditing Course (6th Feb 2018 - 7th Feb 2018 )
C8421 Advanced Auditing Skills: Audit Analysis and Reporting (6th Sep 2017 - 7th Sep 2017 )
C8422 Advanced Auditing Skills: Audit Analysis and Reporting (21st Feb 2018 - 22nd Feb 2018 )

Webcasts

Webcast - Audit Programmes: The Basics
Webcast - Clinical Investigator EU CT Regulation
Webcast - Where Does Audit End?

eLearning Products

Introduction to Managing an Audit Programme elearning
Introduction to the Audit Process elearning

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