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Audit Programmes and Risk Assessment

CPD Accredited

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Remote Course Face-to-face Course

Course Information

This one day course is designed to provide you with comprehensive guidance and practical help for when designing and implementing audit programmes. Using the guidance of ISO 19011 with reference to PV, GCP, GMP and GLP audit programmes, you will 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 you 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 your circumstances, challenges, common issues and ways to approach managing audit programmes with other delegates on the course.

Tutors

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

Louise Handy

Louise Handy

Director, Handy Consulting Ltd

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Louise Handy

Programme

Please note timings may be subject to alteration.

Day 1

08:50

Registration

09:00

Welcome and Introduction

09:15

Why do we Need to Audit?

Exploring risk and regulation, responsibility and performance.

09:45

Discussion - Programmes, Needs, Commonalities

Understanding the needs of delegates' own organisation and comparing common themes and threats.

10:00

Establishing an Audit Programme

Design, objectives, risk and resources. This session discusses the consideration when designing audit programmes.

10:30

Break

10:45

Risk Management

Considerations, guidance and methods for assessing and controlling risk.

11:00

Workshop 1 - Risks, Prioritisation and Control

Looking at specific risks, assessing and evaluating to feed into audit programme management.

12:00

Workshop 1 - Feedback

12:30

Lunch

13:30

Putting it into Practice

Resources, practicalities and challenges - the realities of auditing, including selection of auditors, ensuring practice will meet expectations and the reasons to note audit results.

13:45

Workshop 2- Designing Audit Programmes

Designing audit programmes using output from risk assessment process. Challenges and flexibility.

15:00

Break

15:15

Workshop 2 - Feedback

15:30

Monitoring, Reviewing and Improving

Why or when should existing processes change, 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

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

7 Points

Development Level

Develop

  • Both presenters were very knowledgeable and able to enliven discussion with examples from their own experience, which is always incredibly valuable.

Book now

Click below for Course dates/fees:

Remote Course Face-to-face Course
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