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ערן יונה CEO- יועץ GXP וטכנולוגיות ייצור מהנדס ביוטכנולוגיה, בעל תואר שני במנהל עסקים. למעלה מ-17 שנות ניסיון רב-תחומי בתעשיות הפרמצבטיקה, המדיקל והביוטכנולוגיה

CE Annex 11, FDA 21 CFR Part 11: Computerized systems and software validation

2020-08-11T09:12:12+00:00July 7th, 2020|

What is software validation? Software validation is part of the computerized systems validation (CSV) process. Computerized systems validation is defined as documented evidence with a high degree of [...]

Good weighing practice (GWP) for laboratory and production balances

2020-08-11T09:13:05+00:00July 7th, 2020|

Introduction Weighing of raw materials, products, reagents, excipients and other product related materials is an area which has risks in the biotechnology and pharmaceutical industries. Any weighing mistake [...]

Good Storage and Distribution Practice (GSP/GDP), cold chain safety and validation

2020-08-11T09:13:45+00:00July 7th, 2020|

Background Good Storage Practice (GSP) and Good Distribution Practice (GDP) describe human, veterinary and investigational drug substance and drug product supply chain procedures and standards for assurance of [...]

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