QA Pharma Training : Fundamentals of Change Management - Initiation to Closure
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- Опубликовано: 12 сен 2024
- Change control management in Pharmaceutical Industry is one of the important part of Quality Management System. This video will provide a very easy way to understand change control management system.
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This is very important topic and now days regulators are more focusing on change control and it's impact on GMP environment.well explained in this video. Thanks for sharing you knowledge Bank for us.
Ultimate video on change management system I. e. From initiation to closure... Highly useful for all pharmaceutical employees especially who are involve in day to day change initiative and review.....
Yes.
Excellent presentation in detailed
Glad you liked it!
nice presentation
Sir , Thanks for sharing.
This is very informative video. Specially, level 1, 2 and 3 classification and based on severity assessment/ required documentation of change control.
This video is very important for every pharma person responsible directly or indirectly for change control. managment..
Eagerly waiting for next video....
Sure!
Very useful to all Pharma professionals
Must needed to learn as per current expectations of all regulatory
Congratulations Sunil! Wonderful initiative to give back to the Pharmaceutical Industry, which has given us so much. Appreciate your willingness to train Pharma professionals who can learn cGMP when they have time. As conveyed I will ask our QA managers to use these Videos as Training program for one and all with some snacks, which you will miss. Bravo to you! This will be your best wealth. Keep it up.
Thank you so much sir for your appreciation and recognising the value of videos which is the need for every freshers in pharma professional.
This is very informative video. Specially, level 1, 2 and 3 classification and based on severity assessment/ required documentation of change control.
This video is very important for every pharma person responsible directly or indirectly for change control. managment..
Eagerly waiting for next video....
3
Thank you.
Your video is exactly...good
I seen all video ...
Thanks and welcome
Thank you so much for sharing your experience on this plateform.
Sir please make a vedio on risk assessment.
Your way of explaination is very nice. Good luck and waiting for your next vedio.
Thanks
Sure.
Thank you.
Good information.....need to make video regrading new product introduction through CC. with case study.
Sure I will
Very useful Video. Thank you sir.
Thank you.
Change control example with full format each n every steps covered, all documents that we need to attach... What barrier comes to deal with qa, production,hods, qc to reach approval, closure, kindly upload the video
Tq sir valuable information please provide 21CFR and CAPA related videos also sir
Ok sure
TQ sir
Nice sir, & thanks for giving valuable knowledge.
Well explained 👍👍
Good evening sir
Please give clarity between temporary change control and plane deviation.
Both are almost same, just difference in presentation. As per guideline, there is only deviation.
nice
Sure.
Thank you.
Thankyou sir...
Very well explained thank you so much. Could you please make the procedure for deviation management as well.
Yes, soon
Provide risk assessment procedure for proposed changes
Sure.
if ccf is initiated to perform protocol base activities for data generation purposes. what is category for this ccf. Effectiveness is required for this ccf?
Thank you sir for sharing
So nice of you
Sir !
TCC now undergo deviation is it correct !
thank u sir
Elaboration of analytical procedure will be consider under what level???
For example---
We are fixing grade of chemicals in STP based on experience and validation.
Elaborate Standard and sample preparation ---- what care to be taken for handling standard and sample.
Elaboration of sample preparation---- how to shake the flask.
It depends, based on factors and parameters which has impact on analytical results shall be elaborated. I agree with examples you have mentioned.
@@SunilSingh-wg9sh I assume it will be level 1 change...... right!!!
How manual tracking to be done for change control
Tracking will be difficult once number will increase. We should have software based control.
How to write the change control log book for periodic review
WHAT ABOUT CROSS FUNCTIONAL TEAMS SIR
How to identify the design of compression machine? Which impact on regulatory filling.
First of all, note down all your requirements then search the machine which can meet your requirements.
Hello sir
How to closer change control in detail
Hello Sir I think u were in Ranbaxy
Yes
Hai sir goodmorning plz explain with examples with documents (case studies different type) plz share me
Sir please share method verification