About me

QUALITIY MANAGEMENT

REGULATORY AFFAIRS

I’ve been working since more than 15 years in the field of medical devices,  pharmaceutical, biotechnological as well as phytopharmaceutical industries.

 

I gained my experience in big as well as medium – sized companies. My field of work ranged from management representative (ISO 13485 and 21 CFR 820) and the maintaining of the quality management system, complaint management as well as the certification of medical devices and as head of the quality control.

 

Since spring 2011 I work as a freelancer for consulting and auditing.

 

Amongst others (examples) I aquired the following qualifications:

 

FDA’s cGMP for Finished Pharmaceuticals

FDA’s cGMP for Medical Devices

Medical Device Regulatory Affiars

DGQ – Qualitätsbeauftragte und interner Auditor

DGQ – Auditor Qualität

© 2020  Ulrike Zilz Consulting  -  phone +49 8143 9999525  -  mobile +49 179 1333283

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