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ביו-כם שירותי ולידציה, רגולציה ופיתוח תהליכים, GMP, QA

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כתבות ומאמרים אחרונים

Medical Devices registration/submission in Israel
December 2, 2018
Medical devices Cleaning Validation
January 16, 2018
Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries
November 30, 2017
Surface Finish and Biocompatible Materials for Pharmaceutical and Medical Devices
October 3, 2017
Cleaning medical devices techniques and validation
September 18, 2017

צוות המומחים

Avital Liebenson
Validation & QA Referent Avital is currently pursuing her B.Sc in nutrinional science and serves as a validation and QA referent. info@bio-chem.co.il
Galia Berger B.Sc
Validation & Process Engineer Galia has 5 years' experience in microbiology, molecular biology, Quality Assurance, and validation. Prior to joining Bio-Chem, Galia worked as a QA engineer in a leading pharmaceutical company and was responsible for handling customer complaints, deviation management, CAPA, risk assessment, and GMP inspections & training. Afterwards, she worked as a Validation…
Shay Golan
Process, Validation and Medical Device technician
Process, Validation and Medical Device technician Shay has 10 years of experience in Medical Device prototype development, Bio-Pharma Process Engineering, Validations, Technical consulting and Maintenance. Prior to joining “Bio-Chem Engineering”, Shay was involved in Food & Supplements Process Development and technology improvement, GMP assimilation and Cleaning Validation in the food and supplements industry. Shay has…
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Ofir Levi
Analytical methods development and validation
Analytical methods development and validation Ofir has 15 years’ experience in Analytical Chemistry in the Pharmaceutical and Biotechnology industries. Prior joining Bio-Chem Engineering, Ofir had experience in several Analytical Chemistry, Quality Control, analytical methods development and Validation projects. He also established and assimilated GMP and GLP laboratory standards. info@bio-chem.co.il
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He.Maya
Regulation and QA consultant
Regulation and QA consultant Maya has more than 15 years of experience in the Biotech industry, 10 of them in Regulatory Affairs and Quality Assurance positions. Prior joining Bio-Chem, Maya served is several QA and RA positions and led Bio-Pharmaceutical and Medical Device companies to successful regulatory approval. Maya has rich practical experience in QA,…
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Smadar Seri
Computerized systems, software, control and Medical applications Validation
Computerized systems, software, control and Medical applications Validation Smadar is experienced in Biotech R&D and software Verification & Validation (V&V). Prior joining Bio-Chem, Smadar managed software development projects, SEO, social networks and websites design. info@bio-chem.co.il
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