Case Studies Audit
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Case Study |
Auditing
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Audititing work for the Medical Devices Agency of the Department of Health
Prior to the introduction of the Medical Devices Directive, Notified Bodies and the Medical and HealthCare Regulatory Agency Manufacturers were regulated by this agency.
I did 38 manufacturer audit in just over a two year period received 20 unsolicited testimonials to the effectiveness, helpfulness and positive nature of the audits.
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Auditing
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The pre-qualification of five Bio-pharmaceutical establishments across the UK, Beligium and the US for a large Bio-pharmaceutical manufacturer against PS 9000 for excipients provided invaluable experience and understanding of this application of Good Manufacturing Practice to a specific sector of Bio Pharmaceutical manufacturing.
The sites included a contract research laboratory, a temperature controlled specialist courier company, a repackaging company, manufacturer of water for injection and an aseptic filling company.
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