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Articles By company connects consultancy

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How To Become Certified Computer System Validation (csv) Professional For Pharmaceutical Industry?    Submitted as: Company Connect Consultancy
Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifying a regulated (E.g., FDA 21CFR11) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper records. This is widely used in the Pharmaceutical, Life Sciences and Biotech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules.(read entire article)
View : 635 Times
Category : Career

Pharmacovigilance Post Pandemic    Submitted as: Madhuri
As per a recent analysis by Emergent Research, the Pharmacovigilance market is expected to be valued at $12 billion by 2027, an indication of rapid growth in the sector post COVID. To be able to leverage such growth opportunities, the Pharmacovigilance industry is increasingly adapting to new trends attributed to better and more effective data collection and analysis.(read entire article)
View : 108 Times
Category : Education

Medical Writing    Submitted as: Madhuri
Become a certified Medical writer from best Institute in India Changing market dynamics, expiring patents, and depleted product pipelines are all exerting pressure on pharmaceutical companies to outsource non-core activities in an effort to control costs and enhance drug-development cycle time. One of these activities is medical writing—an area that, although not at the core of pharmaceutical operations, has become increasingly critical as regulatory agencies have adopted more elaborate review measures that requires substantial amounts of documentation.(read entire article)
View : 145 Times
Category : Career

Drug Regulatory Affairs    Submitted as: Company Connect Consultancy
Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities' attitudes and requirements etc. have a great influence on the drug development process and the success of it. Regulatory affairs professionals deal with these aspects.(read entire article)
View : 138 Times
Category : Career

Herbal Drug Regulatory Affairs    Submitted as: Company Connect Consultancy
Get trained in Regulatory affairs from one of the best institute in India.(read entire article)
View : 124 Times
Category : Career

Computer Software Assurance    Submitted as: Madhuri Kanade
CSA intends to provide recommendations to life sciences companies on computer software assurance for computer systems and automated data processing systems that are part of medical device production or the quality system.(read entire article)
View : 102 Times
Category : Education

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