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Advanced Auditing Skills: Audit Planning and Performance

A 20% discount is available off the course fees for Advanced Auditing Skills: Audit Analysis and Reporting when also booking Advanced Auditing Skills: Audit Planning and Performance. 
To take advantage of this discount, please add both courses to your basket and enter AAS at the checkout.

  

RQA CPD Stamp

Course Information

This is an advanced skills course, which will focus on improving the auditor’s performance during audit preparation and conduct, including tips and new strategies to try. Delegates will be expected to reflect on and share their own previous experiences.

This course has the option of Audit Clinics where delegates may request a 1-1 session with a course tutor for advice on any aspect of the audit process.

Who should attend:

  • Experienced GxP and other scientific auditors with at least 1 year’s auditing experience
  • Auditors who have previously attended an entry level audit course
  • Intermediate +.

Course Tutors

Tutors will be comprised from the list below:

Shirley Hallam
GCP Auditor and Clinical Research Consultant, Hallam Pharma Consulting Ltd (Course Principal)

Joy Eldridge
Head of Research Quality Assurance, Mundipharma International Technical Operations

Bev Brummitt
Director, Wider Perspectives Limited

CPD Points

10 Points

Course Programme

Please note timings may be subject to alteration

 

Day 1

12.00 Registration/Lunch
13.00 Welcome and Course Objectives
Delegates' Goals and Experiences.
Introduction and Course Aims:
To maximise the value of audit activities on site by effective preparation
To further develop recording and note taking skills
To improve evidence collection through effective communication.
14.00 Workshop 1 - Audit Plan - Group Work
14.25 Workshop 1 - Feedback
14.40 Audit Planning
What is the purpose of an audit plan, and what should it contain?
15.00 Break
15.15 Audit Preparation
How to prepare for a successful audit.
Workshop introduction.
15.45 Workshop 2 - Audit Preparation - Group Work
Exercise - introduction to the case study, audit of a contract laboratory.
17.15 Wrap Up and Close of Day
17.30 Audit Clinic - Optional
Delegates may request a 1-1 session with a course tutor for advice on any aspect of the audit process.
   
 

Day 2

9.00 Review of Day 1
9.10 Workshop 3 - The Opening Meeting
Introduction - setting the tone and expectation.
10.15 Break
10.30 Collecting and Recording Audit Evidence
Presentation: Consideration of various recording methods for different audit scenarios, including interviewing, facilities tour, observing practice, document review.
     - Recording styles
     - Use of media
     - Filtering information
     - Use of checklists
Delegates will be invited to share their own methods and tips.
11.30 Workshop 4 - Checklist Task
12.15 Lunch
13.00 Dealing with Difficult Situations
Interactive discussion - time to share our audit horror stories!
Presentation - how to get the best out of your auditees.
13.30 Good Interview Practice
Presentation - interview techniques.
14.45 Workshop 5 - Auditee Interview
15.00 Break
15.15 Process Observation
Introductory presentation.
Workshop 6 - Process Observation
16.15 Summary of Course and Wrap Up
An opportunity for further open discussion of issues raised by the course.  Revisiting delegates' objectives to ensure they have been met.
17.00 Close of course

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.

Additional Requirements
(not included in course fees)

Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities). If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.
Bed and Breakfast is £77*, dinner is £35*  (* per night per person) - these can be selected during the booking process.

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Recommended Products

Booklets

Management of the Training and Competency of Personnel in GxP and Research Environments
Pharmacovigilance Auditing

Courses

P01 Introduction to Computer Systems Validation
P02 Good Clinical Practice Auditing - Principles and Practice
P04 Quality Assurance for Good Laboratory Practice
P08 The Auditing Course
P11 A Systems Approach to Good Pharmacovigilance Practice
P21 Audit Programmes and Risk Assessment
P34 Practical Approach to Auditing Systems and Processes
P35 Practical Pharmacovigilance Auditing
P42 Advanced Auditing Skills: Audit Analysis and Reporting

Webcasts

Webcast - Where Does Audit End?

eLearning Products

Introduction to Risk Based Quality Systems (RBQS) elearning
Introduction to the Audit Process elearning

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