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...
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Madhuri Kanade
- Nov 24, 2022
- 3 min
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, 2022
- 5 min
DRUG REGULATORY AFFAIRS
Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees...
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Madhuri Kanade
- Oct 6, 2022
- 4 min
Medical Writing
Become a certified Medical writer from best Institute in India Changing market dynamics, expiring patents, and depleted product pipelines...
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Madhuri Kanade
- Sep 25, 2022
- 4 min
Pharmacovigilance: Post Pandemic
Get Best training and certification in Pharmacovigilance The History of Pharmacovigilance roots back to the rise in awareness among...
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Madhuri Kanade
- Jul 28, 2022
- 4 min
Computer System Validation (CSV) In Pharmaceutical Industry
Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifyi...
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Madhuri Kanade
- Jul 26, 2022
- 8 min
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...
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Madhuri Kanade
- Jul 21, 2022
- 8 min
Clinical Data Management
coClinical data management leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps...
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Madhuri Kanade
- Jul 15, 2022
- 6 min
Pharmacovigilance
Knowing What Pharmacovigilance is? According to WHO Pharmacovigilance is the science and activities relating to the detection,...
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Avneesh Pandey
- Jun 12, 2022
- 5 min
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...
616 views2 comments
companyconnectc
- Apr 24, 2022
- 5 min
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...
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companyconnectc
- Apr 24, 2022
- 3 min
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...
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companyconnectc
- Apr 24, 2022
- 2 min
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...
213 views0 comments
companyconnectc
- Apr 24, 2022
- 1 min
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...
145 views0 comments
companyconnectc
- Apr 24, 2022
- 3 min
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...
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Brajesh Parmar
- Apr 23, 2022
- 11 min
Industry 4.0 & Pharmaceutical Manufacturing : Digital Factory of Next Generation
The term Industry 4.0 refers to the fourth industrial revolution which brings together rapidly evolving technologies such as the internet...
312 views1 comment
Bhumika Barve
- Jan 23, 2022
- 6 min
Change Management
ello Readers, Hope it was a great weekend. And now as the night grows darker, and the day prepares to change from Sunday to Monday,...
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Bhumika Barve
- Jan 18, 2022
- 9 min
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...
74 views1 comment
Brajesh Parmar
- Jan 15, 2022
- 7 min
Computer Software Assurance: New Way of Computerized System Validation
Now a days everyone is shifting from CSV to CSA, a risk based and more efficient validation approach as compared to generating piles of...
316 views0 comments
companyconnectc
- May 29, 2021
- 4 min
Computerized System Validation
Computer System Computer hardware components assembled to perform in conjunction with a set of software programs, which are collectively...
175 views0 comments
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