Continued Process Verification

#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 - kzbin.info_0NDBOVfjHk?...
Link for FDA guideline for process validation - www.fda.gov/regulatory-inform...
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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[@balvinderkumar5383]

Appreciate sir, and thank you Keep uploading informated and valuable videos...request to do on stratified sampling also...

[@hitendrakumarshah3718]

Sure. Will do it

[@sonikumar7269]

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]

sure. You can refer the FDA stratified sampling guide for details. This guideline is not implemented but still provides good understanding.

[@Bharatpithiyalive]

Sir... Kindly share link of FDA guidelines

[@hitendrakumarshah3718]

I have uploaded all relevant links in description section.

[@prashantpandey668]

Need presentation

[@hitendrakumarshah3718]

Thank you for your kind comment

[@masthangm4836]

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]

Because, all CQA and CPP data are collected to demonstrate the process stability.

[@masthangm4836]

​@@sarvilsanavBro! I have mentioned PQR which is Product Quality Review not PPQ! 😊

[@hitendrakumarshah3718]

The data from PQR can be used to evaluate process capabiilty and not process stability.

[@masthangm4836]

Thanks alot Sir! 👌👍