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Continued Process Verification

  Рет қаралды 2,270

Hitendrakumar Shah

Hitendrakumar Shah

Күн бұрын

#pharmaceutical #csv #csa #validation #quality #qrm #riskmanagement #fda #compliance #gmp #ich
This session will make you understand the "Continued Process Verification" requirements in line with the various guideline expectations for example - EUGMP, FDA, WHO guide etc.
The agenda for this session is as below;
Understanding Continuous Process Verification - Importance, Need and Purpose
Know your Trainer
Difference between ‘Product Quality Review’ and ‘Continuous Process Verification’
Guideline Requirements - USFDA, EU, WHO etc.
Difference between USFDA and EU Regulations for Process Validation
Role of Continued Process Verification in process validation and its practical implementation
FDA Citations on Continued Process Verification
Q&A
Vote of Thanks and contact details
Subscribe - / @hitendrakumarshah3718
Link for webinar of Process validation - Regulatory and Practical View - kzfaq.info...
Link for FDA guideline for process validation - www.fda.gov/re...
Link Process Validation - Key Questions and Answers 1 - • Process Validation - K...
Link Process Validation - Key Questions and Answers 2- • Process Validation - K...
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Пікірлер: 13
@balvinderkumar5383
@balvinderkumar5383 6 ай бұрын
Appreciate sir, and thank you Keep uploading informated and valuable videos...request to do on stratified sampling also...
@hitendrakumarshah3718
@hitendrakumarshah3718 6 ай бұрын
Sure. Will do it
@sonikumar7269
@sonikumar7269 3 ай бұрын
Thank u very much Sir ji for valuable information. I have question related to data point. As u suggested 20 data point. Please help for details information related 20 data points with example for better clarity.
@hitendrakumarshah3718
@hitendrakumarshah3718 Ай бұрын
sure. You can refer the FDA stratified sampling guide for details. This guideline is not implemented but still provides good understanding.
@masthangm4836
@masthangm4836 6 ай бұрын
Very comprehensively the subject is elaborated, thanking indeed. Can we not use the data collection from PQR to establish process stability as they are intra batch data? In spite of ongoing program. Please advise.
@masthangm4836
@masthangm4836 6 ай бұрын
Because, all CQA and CPP data are collected to demonstrate the process stability.
@masthangm4836
@masthangm4836 6 ай бұрын
​@@sarvilsanavBro! I have mentioned PQR which is Product Quality Review not PPQ! 😊
@hitendrakumarshah3718
@hitendrakumarshah3718 6 ай бұрын
The data from PQR can be used to evaluate process capabiilty and not process stability.
@masthangm4836
@masthangm4836 5 ай бұрын
Thanks alot Sir! 👌👍
@Bharatpithiyalive
@Bharatpithiyalive 6 ай бұрын
Sir... Kindly share link of FDA guidelines
@hitendrakumarshah3718
@hitendrakumarshah3718 6 ай бұрын
I have uploaded all relevant links in description section.
@prashantpandey668
@prashantpandey668 6 ай бұрын
Need presentation
@hitendrakumarshah3718
@hitendrakumarshah3718 6 ай бұрын
Thank you for your kind comment
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