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European Pharmaceutical Contractor

Unfamiliar Grounds

Audit preparation can seem like a daunting task, especially when the subject area is complex or unfamiliar. It is often a balancing act between competing priorities and expectations, as well as being vigilant that the audit remains a quality assurance exercise (i.e., scratching the subject surface and verifying compliance through information sampling).

Know the Audit Scope

Very rarely are auditors in a position to attend an audit with little preparation. To do so would only set the audit up for disaster as essential audit objectives may not be met, with time spent on activities that were not a priority for the audit outcome.

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About the author

Iain Pulley is a GCP auditor with over 12 years of experience auditing both global pharmaceutical organisations and clinical trials. With a BSc (Hons) in Product Design, he is passionately process-orientated and places a strong emphasis on ensuring quality management systems add value to achieve right-first-time results. Iain has also successfully assisted and coached various organisations in preparation for receiving regulatory authority inspections.
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