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computer system validation Good automated Pratices GAMP5-Quality risk managment
An institutional review board (IRB)also known as an Independent Ethics Committee(IEC),is committee r...
Regulatory requirements of BIOAVAILABLITY & BIOEQUIVALENCE STUDIES
Main regulatory agencies involved in Clinical Trial in nutshell
Human error is a frequent cause of allergen-related recalls in food manufacturing, often happening w...
Blend unifrmity is important for drug containing 50% or 50 mg API
good manufacturing practices for finished pharmaceuticals (21 CFR 211)
CSV
it covers definitions of GMP, cGMp, objectives of cGMP, benefits, plant layout, equipment maintainan...
Pharmaceutical Equipment Validation
this ppt talks about glp principles overview, the way it is implemented in various countries, and a ...
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About the pharmacovilgilence
This presentation is prepared based on USFDA Guidance "Orange Book Questions and Answers" ...
Good Clinical Practices and Investigator responsibilities
Professional certification can provide added credentials for those who look for greater career succe...
Investigational new drug application approval process and IND detailed information//INDA//
cosmetic regulatory
It is applicable for the Generic drugs
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review an...
This presentation explains in brief the process, types, requirements, and conditions where PAS is ne...
In this slide contains details about Validation master plan. Presented by: HIMA BINDHU (Department...