Self Inspection (internal audit) Training

Audit Preparation Training Course

This Audit Preparation Training Course is designed to provide participants with detailed knowledge of the external audit process and the roles and responsibilities of an auditee.

This course will help you to understand how to prepare your work environment, what to expect on the day of the audit (both onsite and remote audits), what auditors will ask for or look for, and how to respond to audit findings.

It will help take the stress and anxiety out of an upcoming audit and leave you feeling ready for the audit day.

Audit Preparation Training Course

Overview

This Audit Preparation Training Course is designed to provide participants from the health care products industry with detailed knowledge of the external audit process and the roles and responsibilities of an auditee. It’s applicable to ISO9001, ISO13485, GMP and GCP inspections.

This course will help you to understand how to prepare your work environment, what to expect on the day of the audit (both onsite and remote audits), what auditors will ask for or look for, and how to respond to audit findings.

It will help take the stress and anxiety out of an upcoming audit and leave you feeling ready for the audit day.

What you will learn

By the end of this course, participants will have a practical understanding of:

  • The various types of audits and their aim
  • Audit process overview (ISO19011:2018 Guidelines for auditing management systems)
  • Roles and Responsibilities of the Quality Team, Audit Team and Auditees
  • Getting Ready – Audit Preparation including, opening presentation, Front and Back-room preparation and the differences between preparing for an onsite or remote audit
  • Preparing your department
  • Documentation and records
  • How to deal with stress and anxiety
  • Audit Day – What to expect when they’re inspecting including, opening meeting, collecting and verifying information, interviews, answering questions.
  • Body language tips
  • Conducting site tours/ walk throughs.
  • Managing audit requests
  • Post-Audit – what happens next? Responding to audit findings

Course format

The course is a combination of lecture-style learning and active workshops, with participants working in small groups on assigned tasks and case studies.

Course materials

Participants will receive a soft copy of the presentation(s), relevant notes and workshop materials. A certificate of completion will be issued to participants who successfully complete the assessment.

Assessment

A written assessment is conducted at the end of the course.

Who should attend?

  • Quality Assurance personnel
  • Quality Control personnel
  • Operations and Manufacturing personnel
  • Qualification & Validation personnel
  • Engineering & Automation personnel
  • Anyone within the GMP industry who will be participating in an audit as an auditee.

Price

AUD $300 + 10% GST Half-Day Virtual Training

Prices are per person and include morning tea, lunch and afternoon tea (Note: Excluded for virtual training sessions)

Register

Register for the Audit Preparation Workshop below:
If you need any assistance in booking or would like a quote for personalised training at your site, please do not hesitate to contact us at one of our offices around the world.

Event Venue Date
Audit Preparation Workshop Virtual Virtual Training
  • 18-Apr-2024 9:00 am
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Auditor Workshop Virtual Virtual Training
  • 23-Apr-2024 9:00 am
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Audit Preparation Workshop Virtual Virtual Training
  • 11-Jul-2024 9:00 am
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Auditor Workshop Virtual Virtual Training
  • 27-Aug-2024 9:00 am
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