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Medical Device equipment

Remote audits - Why, when and how

– How to make sure a remote audit is efficient and relevant

WEBINAR - 1 December


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.

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.

Course content:

  • 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.

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.

Need of prior knowledge/experiences

  • 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.

 

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Course facts

Course no:
5813
Industry:
Medical Devices and
Pharmaceuticals

Level:
Intermediate
CS/GMP region:
EU/US

Language:
English

Instructors:
  
Åse Ek and Anna Lundén

Date:
1 December 2020 - Online


Time:
10.00 - 11.30 CET (Central European Time)

Price (excl. local VAT):
250 Euro
Course handouts (PDF) and certificate of attendance is included.


Discounts:
For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.


Equipment needed:
You need access to a computer, tablet or mobile phone with internet connection (preferably min 1MBit/s) and audio capabilities (speakers or headphones).
We are using the easy-to-use applications "GoToWebinar" and "GoToMeeting".
See more about how to join a session and the system requirements here »

Instructions will be attached to your order confirmation.


Cancellation policy for webinars:
Cancellations received less than 7 days before the webinar will be charged 50% of the course fee.
Cancellations received less than 24h before the webinar will be charged 100% of the course fee.

If you for any reason is unable to attend, substitution is always possible and preferred. All cancellations and/or substitutions must have been communicated with and confirmed by us.

In case of failure to cancel before the course, the course fee will be charged in full.


Cancellation of webinars:
Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value.