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companyconnectc
Nov 16, 20232 min read
Artificail Inteligence, Machine Learning and Computerized System Valiation Approach
Approach for validating computerized systems in the context of artificial intelligence and machine learning involves a comprehensive and...
146 views0 comments


Madhuri Kanade
Dec 6, 20223 min read
Regulatory Medical Writing
Drug development is a billion-dollar industry featuring a variety of roles necessary to pursue the goal of product approval. A crucial...
58 views0 comments


Madhuri Kanade
Nov 24, 20223 min read
Herbal Drug Regulatory Affairs
Herbal medicines, known as phytomedicines or botanical medicines (Phyto- Plant) contains plant parts like, leaves, roots, stem, flowers,...
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Madhuri Kanade
Nov 1, 20225 min read
DRUG REGULATORY AFFAIRS
Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees...
71 views1 comment


Madhuri Kanade
Oct 6, 20224 min read
Medical Writing
Become a certified Medical writer from best Institute in India Changing market dynamics, expiring patents, and depleted product pipelines...
98 views1 comment


Madhuri Kanade
Sep 25, 20224 min read
Pharmacovigilance: Post Pandemic
Get Best training and certification in Pharmacovigilance The History of Pharmacovigilance roots back to the rise in awareness among...
29 views1 comment

Madhuri Kanade
Jul 28, 20225 min read
Computer System Validation (CSV) In Pharmaceutical Industry
Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") is the process of...
3,945 views0 comments


Madhuri Kanade
Jul 26, 20228 min read
Clinical Drug Development process and it’s Online Training
Developing a new drug from original idea to the launch of a finished product is a complex process which can take 12–15 years and cost in...
38 views0 comments


Madhuri Kanade
Jul 21, 20228 min read
Clinical Data Management
coClinical data management leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps...
78 views0 comments

Madhuri Kanade
Jul 15, 20226 min read
Pharmacovigilance
Knowing What Pharmacovigilance is? According to WHO Pharmacovigilance is the science and activities relating to the detection,...
60 views1 comment


Avneesh Pandey
Jun 12, 20225 min read
Computer Software Assurance (CSA) : Critical Thinking and Risk Based Approach
The Purpose of this Blog is to Provide guidance for the industry on the key concepts of Computer Software Assurance and provide direction...
1,290 views2 comments


companyconnectc
Apr 24, 20225 min read
USFDA 483 on Access Management of Computerized System
Observation 1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized...
586 views0 comments

companyconnectc
Apr 24, 20223 min read
FDA recommendation on Deleting Electronic Data
Hybrid Systems (Deleting Electronic Data) In Hybrid systems the computerized system is used to generate a record which is printed and...
126 views0 comments


companyconnectc
Apr 24, 20222 min read
FDA Observation of Excel Spreadsheets Validation
Observation 1. Your firm has not established and documented the accuracy, reliability and performance of your computer systems employed...
426 views0 comments


companyconnectc
Apr 24, 20221 min read
FDA Observation on Validation of Computerized System
Observation Failure to maintain a written record and appropriate validation data of computer or other automated processes used to perform...
275 views0 comments


companyconnectc
Apr 24, 20223 min read
Electronic Records – CSV FDA Warning Letters
Observation We remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have...
390 views0 comments
Bhumika Barve
Jan 23, 20226 min read
Change Management
Hello Readers, Hope it was a great weekend. And now as the night grows darker, and the day prepares to change from Sunday to Monday,...
64 views0 comments
Bhumika Barve
Jan 18, 20229 min read
Basics of Project Management
Hello Readers, In today's fast-paced developing professional world, every individual should be at par with the most required soft skill...
81 views0 comments


companyconnectc
May 29, 20214 min read
Computerized System Validation
Computer System Computer hardware components assembled to perform in conjunction with a set of software programs, which are collectively...
276 views0 comments


companyconnectc
May 29, 20213 min read
Category Of Software & Hardware As Per GAMP Guideline & their Validation
Category of software Application are categorized into following software categories as per GAMP 5 guideline 1. Category 1 –...
6,359 views0 comments
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