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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.

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

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 Ltd

Claire Dockerill
Associate Director GLP & Research QA, Astrazeneca

 

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)

Accommodation is available at Madingley Hall for the dates of the course. 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.

Course Programme

DAY 1

11.00 Audit Clinic – Optional
Delegates may request a 1-1 session with a course tutor for advice on any aspect of the audit process
11.50 Registration
12.00 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.
15.45 Workshop 2 – Audit Preparation - Group Work
16.45 Workshop 2 - Feedback
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

19.00 for 19.30 Course Dinner


DAY 2

9:00 Review of Day 1
9:10 The Opening Meeting
Introduction – setting the tone, and expectations.
9:20 Workshop 3 – Opening Meeting - Group Work
9:40 Workshop 3 – Presentation and Feedback
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.
11.45 Dealing with Difficult Situations
Interactive discussion – time to share our audit horror stories!
Presentation – how to get the best out of your auditees
12.45 Lunch
13.30 Good Interview Practice
Presentation – interview techniques
Role play by tutors with delegate observation, discussion and feedback
15:00 Break
15.15 Process Observation
An opportunity for delegates to practice observation and recording techniques
16.30 Summary of Course and Wrap Up
17.00 Close of course

 

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Recommended Products

Booklets

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

Courses

C8022 GCP Auditing - Principles and Practice (11th Sep 2017 - 13th Sep 2017 )
C8041 Research Quality Assurance for GLP (26th Sep 2017 - 27th Sep 2017 )
C8082 The Auditing Course (30th Oct 2017 - 31st Oct 2017 )
C8412 Advanced Auditing Skills: Audit Planning and Performance (19th Feb 2018 - 20th 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 - Where Does Audit End?

eLearning Products

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

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