great explanation, thank you so much!! looking forward to more of such videos.
@FernandaWaechterКүн бұрын
@@mayuribirajdar3215 thank you dear :)
@srikanthd-gw1rd15 күн бұрын
exceptional
@jaganmohan7942Ай бұрын
Nicely explanation
@pavankumar-ky2syАй бұрын
Good explanation.I want to learn ICH quality and multidisciplinary guidelines from you. Case study examples were superb
@poonamkamble2976Ай бұрын
Ma'am can you please make a detailed video on new requirements for the CEP content (CEP 2.0). Thank you 😊
@jkgupta3334Ай бұрын
Please upload more vedios NDSRI
@017461871592 ай бұрын
Very informative and covered all information in a simplified way.
@surimummadi2 ай бұрын
Lovely presentation 😊
@bablujejurkar6612 ай бұрын
Superb cover all point great !!!! thank for edudacting.....
@dr.balakrishnaaegurla55602 ай бұрын
TQ Ma'm
@sivajivanjinathan2 ай бұрын
Very useful information.. Need your contact number.. E mail id
@sivajivanjinathan2 ай бұрын
Hi mamm h r u
@subbuchikkam85993 ай бұрын
Good information
@krupa.b81533 ай бұрын
Do we need to combine general nitrosamines and NDSRIs while setting specification limit ( considering most potent one) .please suggest
@FernandaWaechter2 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.
@lilianecruz62743 ай бұрын
Obrigada pela aula ❤
@anahappy9623 ай бұрын
Show! Faz um vídeo sobre PGMP.
@anapaulapirescostatereza94023 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!👏
@FernandaWaechter3 ай бұрын
Ahh que alegria ler o teu feedback! Obrigadaa, muito feliz de saber que os vídeos foram úteis :)
@nileshbawane8424 ай бұрын
Nice explained...
@nileshbawane8424 ай бұрын
nicely explained
@nileshbawane8424 ай бұрын
Good
@nileshbawane8424 ай бұрын
Crystal clear explained everything.. great
@nileshbawane8424 ай бұрын
Very informative one
@nileshbawane8424 ай бұрын
Great Fernanada
@kavyasridhanekula96584 ай бұрын
extraordinary explanation, simple yet effective
@FernandaWaechter3 ай бұрын
thank you! :)
@tusharganage98144 ай бұрын
Keep Going dear this help me Lot ❤😊
@FernandaWaechter3 ай бұрын
I'm glad to know this was helpful! :)
@Firoz-lm4sz4 ай бұрын
Good 👍 But you speak very fast In next video please I request you to speak slow for better understanding.
@FernandaWaechter4 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
@vasanthdola67684 ай бұрын
@@FernandaWaechter can you explain about NCE minus one and para iv filing
@muhammadzende18184 ай бұрын
simple & effective. thanks👍
@rashvankhan53194 ай бұрын
Nice explanation madam
@pullareddykarnati2514 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…
@FernandaWaechter4 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.
@pullareddykarnati2514 ай бұрын
@@FernandaWaechter thank you very much for your swift reply.
@zahraddeennuhu81865 ай бұрын
Please what about types and Submission of DMF ?
@FernandaWaechter4 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
@zahraddeennuhu81865 ай бұрын
Wow ,very well explained.
@FernandaWaechter4 ай бұрын
Thank you dear!
@amitgupta-yr5pl5 ай бұрын
Thanks for sharing information
@FernandaWaechter4 ай бұрын
You’re welcome dear!
@arunpawar61275 ай бұрын
Plz share information about updated ICHQ2R2
@ameyatambe81295 ай бұрын
What does gti here mean?
@FernandaWaechter5 ай бұрын
GTI = genotoxic impurity
@varshareddy-we3dv5 ай бұрын
Hi ....you are simply amazing
@Sunriserrs5 ай бұрын
Nice content
@pullareddykarnati2515 ай бұрын
Kindly upload in English.. waiting
@FernandaWaechter5 ай бұрын
Here it is: kzbin.info/www/bejne/rHybh4mPh7WimbM
@septiaanrml5 ай бұрын
Such a great vid, very well explained! And this is coming from someone who just recently entered regulatory affairs :)
@FernandaWaechter5 ай бұрын
Thank you, that's great to know! :)
@carollouren71355 ай бұрын
Muito bom esse vídeo Fernanda. seria interessante se você fizesse um vídeo explicando um cromatograma. :)
@amitgupta-yr5pl5 ай бұрын
Great fernanda ,thanks for sharing
@FernandaWaechter5 ай бұрын
you're welcome dear!
@franciscomel06 ай бұрын
Boaa
@satnamom46676 ай бұрын
Beautifully explained and represented pictorially. I am a fan of yours dear Frenda🎉
@FernandaWaechter5 ай бұрын
thank you dear! :)
@amitgupta-yr5pl6 ай бұрын
Excellent explanation Fernanda
@FernandaWaechter5 ай бұрын
thank you!
@amitgupta-yr5pl6 ай бұрын
Nicely explained
@FernandaWaechter5 ай бұрын
thank you!
@srinivasulubhavanasi27346 ай бұрын
Explanation is good.add more videos please
@FernandaWaechter5 ай бұрын
thank you! the English version is published every 2 weeks
@amitgupta-yr5pl6 ай бұрын
Explained well Fernanda
@FernandaWaechter6 ай бұрын
thank you!!
@AshwaniKumar-xi5xq6 ай бұрын
Very informative as always
@bhushanborse9176 ай бұрын
Hi Fernanda, I am waiting for english version, please do inform me
@FernandaWaechter6 ай бұрын
HI Bhushan, English version was published today, here it is kzbin.info/www/bejne/mHKrqXiaZ9BgbKc
@TheLari2010ssa6 ай бұрын
Explicar coisas complexas de uma forma simples é uma das mais belas virtudes dos peritos no assunto. Parabéns Fer!
@FernandaWaechter6 ай бұрын
Ahh obrigadaa :)))
@TheLari2010ssa6 ай бұрын
Ah, esses vídeos são maravilhosos. Mais didáticos impossível. Parabéns Fer!