?What is the New Vitamin K-2 MK-7
Vitamin K is an essential nutrient for blood coagulation (blood clotting) and is responsible for helping protein and calcium [...]
Lead Auditor in Israel
Why is Lead Auditor services in Israel are relevant for you? It is a well-known fact that companies from [...]
Ketones vs. Glucose – Interesting Facts
Glucose Production and Use Glucose, a simple sugar made of Carbon, Hydrogen, and Oxygen (C6H12O6), is one of the [...]
Validation for ERP Priority and SAP systems at Pharma and Medical companies
מהי ולידציה למערכות ERP פריוריטי? מערכת ERP היא מערכת ממוחשבת לתכנון משאבי הארגון והיא נמצאת בשימוש כמעט בכל העסקים [...]
mRNA-based drugs platforms for cancer treatment
New mRNA-based drugs platforms for cancer treatment The successful development of mRNA (messenger ribonucleic acid) based on anti-COVID 19 [...]
חשיבות ה- Data integrity בחברות תרופות
חשיבות ה- Data integrity בחברות תרופות אמינות ושלמות הנתונים, או במונח הלועזי Data integrity מאפשרת הן לחברה והן לגופי [...]
GMP Auditor in Israel
What is a GMP audit in Israel? A GMP audit in Israel is an audit that covers the Good [...]
Dietary & Food supplement product registration In Israel
Guidelines for the process of food or food supplement registration in IsraelIf you are planning to distribute your dietary food [...]
Cosmetics product registration and submission in Israel
Guidelines for the process of cosmetics registration/submission in Israel The Department that is responsible to assure the safety and [...]
Corrective and preventive action (CAPA) system
Introduction "Nonconformity" investigation is a very common term used in production and product quality improvement areas in the pharmaceutical [...]
CE Annex 11, FDA 21 CFR Part 11: Computerized systems and software validation
What is software validation? Software validation is part of the computerized systems validation (CSV) process. Computerized systems validation is [...]
Good weighing practice (GWP) for laboratory and production balances
Introduction Weighing of raw materials, products, reagents, excipients and other product related materials is an area which has risks [...]
Good Storage and Distribution Practice (GSP/GDP), cold chain safety and validation
Background Good Storage Practice (GSP) and Good Distribution Practice (GDP) describe human, veterinary and investigational drug substance and drug [...]
Stem cell medicinal products cGMP and cGTP
Background The use of stem cells for therapeutic and clinical applications is a fast growing area in Biotech research [...]
New drug development and regulation from pre-clinical to clinical trials
Background and history The FDA (US Food and Drug Administration) was established in 1901 as a bureau of the [...]
Fermentation in the biopharmaceutical industry
1. Background Many biopharmaceutical and biological products are based on (different) cell-type fermentation. Biopharmaceutical products can be either intracellular [...]
Corrective And Preventive Actions (CAPA system)
1. Introduction "Non-conformity" investigation is very common term being used in production and product quality improvement areas in the Pharmaceutical [...]
CE/FDA Annex 11/21CFR part 11 Computerized System and Software Validation
1. What is software validation? Software Validation is part of the computerized system validation (CSV) process. Computerized system validation defined [...]
Good Weighing Practice for lab and production balance
1. Introduction Weighing raw materials, product, reagents, excipients and other product related materials is a risk procedure in the Biotechnology [...]
Good Storage and Distribution Practice, cold chain Safety and Validation
1. Background Good Storage and Distribution Practice (GSP/GDP) describes human, veterinary and investigational drug substance and drug products [...]
Stem cell medicinal products cGMP and cGTP
1. Background The usage of stem cells for therapeutic and clinical applications is a fast growing area in Biotech research [...]
New drug development and regulation from pre-clinical to clinical trials
1. Background and history The FDA (U.S Food & Drug Administration) was established in 1901 as a bureau of the [...]
Fermentation in the Bio-Pharmaceutical industry
1. Background Many Bio-Pharmaceutical and biological products are based on (different) cell-type fermentation. Bio-Pharmaceutical products can be either intra or [...]
New drug development and regulation from clinical trials to marketing approval
Background After a new investigational drug pre-clinical stage 1 is completed, and a US IND (Investigational New Drug application) [...]
Medical device cleaning techniques and validation
The purpose of medical device cleaning validation is to assure that the medical device cleaning procedure consistently controls potential [...]
Surface finish and biocompatible materials for pharmaceuticals and medical devices
Medical device surface treatment Surface roughness level is a parameter of surface quality, commonly measured as the average deviation [...]
Pharmaceutical and drug product registration and submissions in Israel
The process of pharmaceutical and drug product registration in Israel The main regulatory body for pharmaceutical administration in Israel [...]
Medimor Medical
Medimor (formerly “Galtronics”) was mold injection, antennas and SMT global manufacturer who strategically decided to totally change its business [...]
Medical devices Cleaning Validation
A contaminated medical device may lead to serious implications and risk to the patient/user. Medical device manufacturers must ensure [...]
Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries
The medical and pharmaceutical industries are involved with new product development and manufacturing (such as medical devices & products, [...]
Surface Treatment for Medical Devices
Surface Treatment for Medical Devices Surface roughness level is a parameter of the surface quality commonly measured as the average [...]
Cleaning medical devices techniques and validation
[vc_row][vc_column][vc_column_text] The purpose of medical device cleaning validation is to assure that the medical device cleaning procedure are consistently controls [...]
OTC drugs and cosmetics regulations and good practices
Background and history In 1938, the Federal Food, Drug and Cosmetic Act (FFDCA) granted FDA authorization for regulation of [...]
Webinar Simulation
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New drug development and regulation from clinical trials to marketing approval
[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 [...]
Validation – What is it?
What is Validation? Validation is documented evidence that a process/equipment/system/software/procedure complies with specifications, criteria and requirements which are defined [...]
Fermentation in the Bio-Pharmaceutical industry
[vc_row][vc_column][vc_column_text] 1. Background Many Bio-Pharmaceutical and biological products are based on (different) cell-type fermentation. Bio-Pharmaceutical products can be either intra [...]
New drug development and regulation from pre-clinical to clinical trials
[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 [...]
Stem cell medicinal products cGMP and cGTP
[vc_row][vc_column][vc_column_text] 1. Background The usage of stem cells for therapeutic and clinical applications is a fast growing area in Biotech [...]
Cleaning Validation for Bio-pharmaceutical & Medical Device
Background The definition of "clean" is free from dirt, soil or impurities (chemical/microbial). The cleaning process intend to remove dirt, [...]