Remote audits - Why, when and how

WEBINAR

Solutions and challenges for remote audits

There are many advantages to gain when performing an audit remotely like time savings, reduced costs and less environmental impact while it also brings some limitations, like not being in direct contact with auditees, not being able to inspect products or processes and less opportunities to observe things that goes on outside the meeting room, “in the corridors”. When is it an acceptable approach and when is it not?

As responsible for audits, you will need tools for decisions and also understand how to make remote audits in an efficient way, for those instances it is a suitable solution.

Course description

This webinar provides guidance on aspects to consider in your audit planning when deciding which audits that can be done remotely and also how to prepare and perform remote audits. We will address items such as preparation of the audit plan, documents to request before the audit and what to look for in those documents, sampling of quality records during the audit and how to verify and document conformity and non-conformities. We will also look into interview techniques that may be useful in a remote set-up.

The course is based on the audit principles defined in ISO 19011:2018.

Course outline

• How to assess which type of audits that can be done remotely.
• Risks and challenges in remote auditing and how to mitigate them.
• Audit preparation, aspects to consider when preparing questions, checklist and record sampling.
• Interview techniques.
• How to verify conformity and non-conformity.

Learning objectives

Participants will get to know criteria to apply when assessing whether an audit can be done remotely, how to prepare for remote audits and how to act in the interview situation.

Who should attend

The course is suitable for auditors who perform internal audits or 2nd party audits (i.e. supplier audits) or who are responsible for the organizations audit program/planning and for the decision whether or not to use the option to audit remote. The course will cover both pharma and medical device perspective.

Prerequisites

• You should have at least intermediate knowledge of Quality Systems/GMP.
• You should have 2-3 years of experience from Life Science industry (pharma or medical device) and from doing audits of quality management systems/GMP.

#5813