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Self-inspections and Audits are intended to determine whether the correct procedures are in place (all processes guaranteed, all legislation implemented, correct use of standards etc.), and then of course whether those procedures are applied correctly.
Self-inspections are about internal procedures and their application by their own colleagues. Audits are about others, in particular suppliers and or contract manufacturing organizations. But on the other hand it is about having an audit carried out by others, such as customers or inspections.
The purpose of Self-inspections and Audits is to gain adequate trust; trust in a material (Active Pharmaceutical Ingredient (API), raw material, disposable materials), in a machine, in a service, and so on. And if confidence is too low, the goal will be to determine measures for improvement and to monitor their implementation.
Conducting Self-inspections and Audits is an essential part of the quality system within the Life Sciences Industry (Pharmacy, Medical Devices, Biotechnology, etc.), but also increasingly in the Food Industry. In a number of cases, it is mandatory under legislation.
In particular, Self-inspections can in principle be carried out by anyone within the company. But it is not easy to tell colleagues that they have to do it differently in such a way that they actually do it differently, and that the management also accepts that. When conducting audits of others, it is important to be open to the way in which the organization being audited does, while at the same time it must be made clear whether this is sufficiently covering. When undergoing an audit yourself, it is important to ensure that it does not go completely the wrong way. It is much nicer if the conclusion of the audit leads to an even better quality system ("free advice").
Content
This training deals with what it means to conduct self-inspections and audits, which good ways must be met and how different techniques can contribute to a good result. Workshops pay a lot of attention to posture.
The following will be covered by this training:
- The ISO-19011 guideline
- Creating Plans and schedules
- Risk Management
- Questions and Attitude
- Scope and agenda
- Kick-off
- Wrap-up
- Reporting and follow-up
- Tips & tricks
Who should attend this training
This training is especially intended for employees who perform or undergo Self-inspections and/or Audits, such as Quality Assurance, Validation employees, Process Experts, Engineers, Laboratory employees, System Experts and IT professionals.
General information
- The student will receive two weeks training for an email training and location details
- The student will receive a certificate after the training
- Lunch and refreshments during the training included
- The student receives at the beginning of the training a binder which includes the printed slides of the presentation.
Trainers
Price
- € 795,00 per student (excluding VAT)
Registration
You can register for this training using the tab 'Training Schedule'.
For information please contact Marcel Schakel, phone +31 (0) 6 49022609 or email This email address is being protected from spambots. You need JavaScript enabled to view it.
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