Quality & GxP

בית/Quality & GxP

Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries

2021-02-16T09:34:52+00:00נובמבר 30th, 2017|

The medical and pharmaceutical industries are involved with new product development and manufacturing (such as medical devices & products, medicines, and combinations thereof). Risk management is a regulatory [...]

New drug development and regulation from clinical trials to marketing approval

2015-05-20T07:19:52+00:00מאי 20th, 2015|

[vc_row][vc_column][vc_column_text] 1.   Background After new investigational drug pre-clinical stage 1 was completed, and IND (Investigational New Drug application) or CAT (Clinical Trial Application) submission to the FDA or CE [...]

New drug development and regulation from pre-clinical to clinical trials

2014-07-21T07:20:03+00:00יולי 21st, 2014|

[vc_row][vc_column][vc_column_text] 1.   Background and history The FDA (U.S Food & Drug Administration) was established in 1901 as a bureau of the Chemistry Department of Agriculture. Five years later, a [...]

Corrective And Preventive Actions (CAPA system)

2012-01-22T07:20:22+00:00ינואר 22nd, 2012|

[vc_row][vc_column][vc_column_text]1. Introduction "Non-conformity" investigation is very common term being used in production and product quality improvement areas in the Pharmaceutical and Medical Devices world. It is mandatory and considered [...]

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