Value Addded Auditing Techniques

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This learning video will make you understand about difference between Traditional auditing and value added auditing.
Further it will focus on difference in Quality Risk Management Approach and scope for Traditional auditing and value added auditing.
This video overall will be helpful for all internal auditors, vendor auditors, third party auditors and many more to upgrade their skills on auditing,

[@hitendrakumarshah3718]

Dear all; Good Evening !!! Welcome to our next training session.

[@janmejaypatel9915]

How to handle material spilled through bottom sieve of FBP bowl during unloading manually?? Should it be discarded?
if we lay plastic bag under bowl and reuse them what would be challenge wrt GMP?

[@hitendrakumarshah3718]

It depends on stage and type of material. I suggest, you need to evaluate and investigate in detailed before reusing the material.

[@janmejaypatel9915]

What would be the best practice to collect material adhered to retarding chamber after drying in FBP? Does it require any scrapper use? Or can it be collected manually??

[@hitendrakumarshah3718]

You can use scrapper. But ensure that, it is not making scratches to your equipment. Otherwise, the material may get contaminated with the traces of metallic impurites. Also, due to scratches, it may become hard to clean.

[@hitendrakumarshah3718]

Please put your questions in comment section

[@gtrivikram8634]

What sort of features auditor will expect from LIMS software during his auditing. Is there any FDA observations & warning letters are issued because of Not fulfilling data integrity recommendations in LIMS or any LIMS software not complying with 21 CFR Part 11 guidelines?? Any case studies are there??

[@hitendrakumarshah3718]

There are lot of features - the auditor should expect from LIMS. Furthermore there are many FDA warning letters about computerised software in Quality controls.

[@hitendrakumarshah3718]

Good Evening all of you !!!

[@gtrivikram8634]

​Hello Mr. Hitendrakumar Shah. Now a days LIMS vendors providing Pre-validation implementation Kit which includes executed OQ videos to skip OQ validation if need and also to Reduce implementation time as LIMS implementation is very extensive. Is it acceptable from FDA audit point of view?

[@hitendrakumarshah3718]

I dont recommed to reduct the OQ validation. The complete document need to be reviewed to ensure, if OQ checks are considered in other document and based on QRM and traceble to requirements.

[@pottasiri]

Hi Sir,
When can we expect your recent webinar (water system) in our UA-cam channel.

[@hitendrakumarshah3718]

If you learn about water system validation, you can go through the link below;
ua-cam.com/video/G8AZWTWX8YM/v-deo.html

[@pottasiri]

@@hitendrakumarshah3718
Good morning
It's my pleasure to get reply from you.
I'm regular follower of all your videos, which makes me more knowledgeable. Thanks for this.
I'm requesting about last week webinar in our UA-cam channel, which I missed while it's streaming.
Please upload.

[@hitendrakumarshah3718]

@@pottasiri Last week webinar was paid webinar. Organised by marketing agency. Hence it is not available in youtube. The FREE learning sessions, I am sharing on youtube.

[@pottasiri]

@@hitendrakumarshah3718 Ok
Thanks Sir.

[@hitendrakumarshah3718]

@@pottasiri Welcome

[@chinthapatlakiran3569]

Yes

[@hitendrakumarshah3718]

Thanks

[@baskar-gz6hq]

Sir I have one doubt vendor COA of one API Having 24 months shelf life for example Dec 2021 to Nov 2023 am going to manufacture manufacture one product using this API what is the criteria for giving manufacturing and expiry date? And can i use same API AT DEC 2022 to manufacturing of two years expiry product please give me clarity

[@hitendrakumarshah3718]

As per Indian FDA (Schedule M) it is not acceptable. the API shelf life should be valid throughout the drug product shelf life as per Schedule M

[@manikantarajugupta9344]

Hai sir If the analyst got 800 results in dissolution what is the next procedure whether the analyst has the raise oot or oos, please clarify my doubt

[@hitendrakumarshah3718]

Your procedure need to have handling of outlier tests. OOS is not applicable as, for dissolution only lower limit will be available.

[@manikantarajugupta9344]

@@hitendrakumarshah3718 tq sir

[@hitendrakumarshah3718]

@@manikantarajugupta9344 welcome

[@thahirs.l.m.slmthahir5413]

Good evening Sir

[@hitendrakumarshah3718]

Good Morning

[@prasad.aprasad447]

Hi sir

[@hitendrakumarshah3718]

Hello !!! Hope you are doing good