Fernanda Waechter

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@pavankumar-ky2sy 7 күн бұрын

Good explanation.I want to learn ICH quality and multidisciplinary guidelines from you. Case study examples were superb

@poonamkamble2976 13 күн бұрын

Ma'am can you please make a detailed video on new requirements for the CEP content (CEP 2.0). Thank you 😊

@jkgupta3334 16 күн бұрын

Please upload more vedios NDSRI

@01746187159 22 күн бұрын

Very informative and covered all information in a simplified way.

@surimummadi 24 күн бұрын

Lovely presentation 😊

@bablujejurkar661 27 күн бұрын

Superb cover all point great !!!! thank for edudacting.....

@dr.balakrishnaaegurla5560 Ай бұрын

TQ Ma'm

@sivajivanjinathan Ай бұрын

Very useful information.. Need your contact number.. E mail id

@sivajivanjinathan Ай бұрын

Hi mamm h r u

@subbuchikkam8599 Ай бұрын

Good information

@krupa.b8153 2 ай бұрын

Do we need to combine general nitrosamines and NDSRIs while setting specification limit ( considering most potent one) .please suggest

@FernandaWaechter Ай бұрын

@@krupa.b8153 Hi Krupa, yes - if more nitrosamines are actually present and need to be controlled in the specification, then you should have a limit for total nitrosamines which may consider the most potent one and NDSRIs should also be considered for this. Unless their mechanism of mutagenicity is different e.g. category 4 or 5 based on CPCA, in which case they fall outside the cohort of concern. In this case I would recommend to confirm with the health authority but I would expect that the NDSRI doesn’t need to be part of that sum for total nitrosamines.

@lilianecruz6274 2 ай бұрын

Obrigada pela aula ❤

@anahappy962 2 ай бұрын

Show! Faz um vídeo sobre PGMP.

@anapaulapirescostatereza9402 2 ай бұрын

Bom dia Fernanda! Assisti a todos os seus vídeos do DMF, parabéns mesmo pelo conteúdo! IFA ainda é um assunto que não é tão explanado como é a Indústria Farmacêutica, obrigada por compartilhar seu conhecimento nesta plataforma, excelente! Você ganhou uma seguidora, que espera um dia fazer a diferença como hoje você está fazendo!👏

@FernandaWaechter 2 ай бұрын

Ahh que alegria ler o teu feedback! Obrigadaa, muito feliz de saber que os vídeos foram úteis :)

@nileshbawane842 2 ай бұрын

Nice explained...

@nileshbawane842 2 ай бұрын

nicely explained

@nileshbawane842 2 ай бұрын

Good

@nileshbawane842 2 ай бұрын

Crystal clear explained everything.. great

@nileshbawane842 2 ай бұрын

Very informative one

@nileshbawane842 2 ай бұрын

Great Fernanada

@kavyasridhanekula9658 2 ай бұрын

extraordinary explanation, simple yet effective

@FernandaWaechter 2 ай бұрын

thank you! :)

@tusharganage9814 2 ай бұрын

Keep Going dear this help me Lot ❤😊

@FernandaWaechter 2 ай бұрын

I'm glad to know this was helpful! :)

@Firoz-lm4sz 3 ай бұрын

Good 👍 But you speak very fast In next video please I request you to speak slow for better understanding.

@FernandaWaechter 3 ай бұрын

Hi dear, sorry that I have spoken a bit faster to avoid the video from getting even longer. If you want, you can choose a slower speed for the video on youtube itself, and most of what I narrate is also written in the video description. Let me know if there is anything you do not understand

@vasanthdola6768 2 ай бұрын

@@FernandaWaechter can you explain about NCE minus one and para iv filing

@muhammadzende1818 3 ай бұрын

simple & effective. thanks👍

@rashvankhan5319 3 ай бұрын

Nice explanation madam

@pullareddykarnati251 3 ай бұрын

Hi is it required to include the Impurities which are used for cut off study/ absence study or single time analysis. For instance, Impurity J is carrying from starting materials which was shown the fate in N-1 / N-2 Stage and same by analysing three consecutive batches.The report submitted.. is impurity J COA and structural elucidation data need to be submitted? Kindly clarify… We performed SM and Intermediates method validations and same were included in DMF.. Are impurities in Starting materials, Intermediates COAs and Structural elucidation need to be submitted? Kindly clarify…

@FernandaWaechter 3 ай бұрын

Hi, since these impurities standards were used for analytical validations even for more simple validations applied to carryover studies, the COA and structural elucidation need to be available, although the regulatory agency may not require them to be included in the DMF. Some consider this as part of GMP compliance and in such case the characterization could be kept in house and provided if requested. I advise you to contact the specific regulatory agency to get clarification on their preferred approach.

@pullareddykarnati251 3 ай бұрын

@@FernandaWaechter thank you very much for your swift reply.

@zahraddeennuhu8186 3 ай бұрын

Please what about types and Submission of DMF ?

@FernandaWaechter 3 ай бұрын

In this video we have only talked about type II DMF - for the drug substance. Other types of DMF can be found here www.fda.gov/drugs/drug-master-files-dmfs/types-drug-master-files-dmfs

@zahraddeennuhu8186 3 ай бұрын

Wow ,very well explained.

@FernandaWaechter 3 ай бұрын

Thank you dear!

@amitgupta-yr5pl 4 ай бұрын

Thanks for sharing information

@FernandaWaechter 3 ай бұрын

You’re welcome dear!

@arunpawar6127 4 ай бұрын

Plz share information about updated ICHQ2R2

@ameyatambe8129 4 ай бұрын

What does gti here mean?

@FernandaWaechter 4 ай бұрын

GTI = genotoxic impurity

@varshareddy-we3dv 4 ай бұрын

Hi ....you are simply amazing

@Sunriserrs 4 ай бұрын

Nice content

@pullareddykarnati251 4 ай бұрын

Kindly upload in English.. waiting

@FernandaWaechter 4 ай бұрын

Here it is: kzfaq.info/get/bejne/rLFoibmKt7bTk4U.html

@septiaanrml 4 ай бұрын

Such a great vid, very well explained! And this is coming from someone who just recently entered regulatory affairs :)

@FernandaWaechter 4 ай бұрын

Thank you, that's great to know! :)

@carollouren7135 4 ай бұрын

Muito bom esse vídeo Fernanda. seria interessante se você fizesse um vídeo explicando um cromatograma. :)

@amitgupta-yr5pl 4 ай бұрын

Great fernanda ,thanks for sharing

@FernandaWaechter 4 ай бұрын

you're welcome dear!

@franciscomel0 4 ай бұрын

Boaa

@satnamom4667 4 ай бұрын

Beautifully explained and represented pictorially. I am a fan of yours dear Frenda🎉

@FernandaWaechter 4 ай бұрын

thank you dear! :)

@amitgupta-yr5pl 4 ай бұрын

Excellent explanation Fernanda

@FernandaWaechter 4 ай бұрын

thank you!

@amitgupta-yr5pl 4 ай бұрын

Nicely explained

@FernandaWaechter 4 ай бұрын

thank you!

@srinivasulubhavanasi2734 4 ай бұрын

Explanation is good.add more videos please

@FernandaWaechter 4 ай бұрын

thank you! the English version is published every 2 weeks

@amitgupta-yr5pl 5 ай бұрын

Explained well Fernanda

@FernandaWaechter 5 ай бұрын

thank you!!

@AshwaniKumar-xi5xq 5 ай бұрын

Very informative as always

@bhushanborse917 5 ай бұрын

Hi Fernanda, I am waiting for english version, please do inform me

@FernandaWaechter 5 ай бұрын

HI Bhushan, English version was published today, here it is kzfaq.info/get/bejne/mKd4q6iVl9GRZnk.html

@TheLari2010ssa 5 ай бұрын

Explicar coisas complexas de uma forma simples é uma das mais belas virtudes dos peritos no assunto. Parabéns Fer!

@FernandaWaechter 5 ай бұрын

Ahh obrigadaa :)))

@TheLari2010ssa 5 ай бұрын

Ah, esses vídeos são maravilhosos. Mais didáticos impossível. Parabéns Fer!

@FernandaWaechter 5 ай бұрын

Obrigada Lari!! :)

@sathishgandu2221 5 ай бұрын

Madam your explanation is very good and we expect more videos from you.

@FernandaWaechter 5 ай бұрын

Thank you dear :)

@bhushanborse917 5 ай бұрын

Good information provided, plz share more valuable information video in future.

@FernandaWaechter 5 ай бұрын

thank you Bhushan! :)

@bhushanborse917 5 ай бұрын

Hi Fernanda ,English version plz , I am waiting

@FernandaWaechter 5 ай бұрын

English version here: kzfaq.info/get/bejne/aZ1og9tim7rbqWw.html

Ең жақсы KZfaq

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