Audit success

The course is designed both for people with internal auditing responsibilities within a company and for those who want to understand how the regulatory audit process works and how to be prepared for an external audit.

As the PIC/s guide to good manufacturing practice for medicinal products states:

“‘Self inspections should be conducted in order to monitor the implementation and compliance…'”

Course Duration & Location

3-5 days, on your site or at one of our training centers.

CiPharma’s training courses can be delivered anywhere in the world. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You’ll save the costs associated with your staff travelling to be trained, so it becomes cost effective if you have several people needing training.

What you will learn

  • Basic definitions of what an audit is, and why audits are important
  • How to practically plan, establish, document and review an audit program, including setting responsibilities and audit program objectives
  • How to conduct an effective audit, including preparation, conducting the opening and closing meetings, audit techniques and how to interview an auditee
  • About common audit findings
  • How to generate audit findings
  • How to prepare an audit report
  • Tips on how to prepare if you are the one being audited (the auditee)

  • Course materials

    Participants will receive a 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.

    Course Format

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

    Who should attend?

  • Quality managers
  • Quality personal
  • Operations and manufacturing personnel
  • Management personnel