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Home  >  Speakers  >  Henry Sibun

Henry Sibun

    BSc (Tech) Hons, MSB CBiol, MCQI CQP
Director | Devon, England    United Kingdom
Immunology And Microbiology
Microbiology, Quality Assurance,...More
Spoken at 2 events

Biography :

Henry Sibun BSc (Tech) Hons, MSB CBiol, MCQI CQP has over 24 years' experience in the medical device industry having worked on three sides of the camp – (1) as a Quality Manager implementing the Medical Devices Directive (MDD), ISO 9001 and EN 46001/ISO 13485, (2) as a Senior Manager, Lead Notified Body Auditor & Technical Expert for the largest Notified Body – TUV SUD Product Service, and (3) as a Consultant & Trainer.

Henry is an IRCA registered Lead Auditor and Chartered Member of both the Royal Society of Biology and the Chartered Quality Institute. After graduating with a 2.1 degree in Applied Biology from the UWIST in Cardiff Henry worked for the Water Board in Sydney completing a large project on microbiological beach pollution as a result of storm-water run-off. On returning to the UK he managed a small QC microbiology laboratory for a food company before moving on to a medical device manufacturer in 1993.

As the Quality Control Manager and Microbiologist, responsibilities included the implementation, the quality system to ISO 9001, EN 46001 and the Medical Devices Directive 93/42/EEC as well as the validation and control of an on-site ethylene oxide sterilizer.

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Immunology and Microbiology

Interested Topics

Microbiology, Quality Assurance, Risk Management, Medical Devices, Quality Auditing, Regulatory Submissions, Biopharmaceuticals, Clinical Trials, Sterilization

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