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 [...]
Validation – What is it?
חשיבות ה- Data integrity בחברות תרופות אמינות ושלמות הנתונים, או במונח הלועזי Data integrity מאפשרת הן לחברה והן לגופי [...]
GMP Auditor
What is a GMP audit in Israel and abroad? A GMP audit in israel is an audit that covers [...]
MRI Technology, Validation & Regulatory Requirements
What is MRI? MRI is a non-invasive medical device that combines medical software for imaging techniques that produce three-dimensional [...]
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 [...]
Cleaning Validation for Bio-pharmaceutical & Medical Device
1. Background The definition of "clean" is free from dirt, soil or impurities (chemical/microbial). The cleaning process intend to remove [...]
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
[vc_row][vc_column][vc_column_text] 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 Finish and Biocompatible Materials for Pharmaceutical and Medical Devices
Medical device surface treatment Surface roughness level is a parameter of the surface quality commonly measured as the average deviation [...]
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, [...]