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14 Dec

External Audits: Do’s and Don’ts

by user
in Uncategorized
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Whether you are being audited by a Notified Body or one of the Regulators, you are being audited by someone external to your organisation. This comes with great opportunities as...

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23 Oct

Audit Backroom Preparation

by user
in Uncategorized
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In this article we focus on how to prepare the audit backroom for a smooth audit. You may have been hosting your audits without much preparation or strategy, and things have...

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02 Feb

Preparing for Opening-Closing Meetings

by user
in Uncategorized
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This is a checklist of tasks to do or check prior and during the opening meeting, as well as items to go through during the closing meeting to ensure a...

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15 Nov

Sampling Plans for Process Validation

by user
in Uncategorized
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How to properly use Quality Sampling for Process Validation? When it comes to sampling of medical devices, we have seen numerous times that the production manager or quality engineer truly wants...

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Recent Posts

  • Sampling Plans for Process Validation
    November 15, 2019
  • Preparing for Opening-Closing Meetings
    February 2, 2020
  • Audit Backroom Preparation
    October 23, 2020
  • External Audits: Do’s and Don’ts
    December 14, 2020

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Latest Posts

  • External Audits: Do’s and Don’ts
  • Audit Backroom Preparation
  • Preparing for Opening-Closing Meetings
  • Sampling Plans for Process Validation

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