July 23, 2024

Some warning letters from FDA will be discussed as case studies

Some warning letters from FDA will be discussed as case studies

Hello Everyone,
Some warning letters for Indian companies will be read and discussed what companies who recieve should do.
Regards
Dr.Afshan Hashmi
http://www.drafshanhashmi.com
http://www.afshanhashmi.com

Meet and Greet with Dr. Afshan Hashmi  is...

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Hello Everyone,
Some warning letters for Indian companies will be read and discussed what companies who recieve should do.
Regards
Dr.Afshan Hashmi
www.drafshanhashmi.com
www.afshanhashmi.com

Meet and Greet with Dr. Afshan Hashmi is broadcast live Tuesdays at 3PM PT on K4HD Radio - Hollywood Talk Radio (www.k4hd.com) part of Talk 4 Radio (www.talk4radio.com) on the Talk 4 Media Network (www.talk4media.com). Movie Reviews and More TV Show is viewed on Talk 4 TV (www.talk4tv.com).

Meet and Greet with Dr. Afshan Hashmi Podcast is also available on Talk 4 Media (www.talk4media.com), Talk 4 Podcasting (www.talk4podcasting.com), iHeartRadio, Amazon Music, Pandora, Spotify, Audible, and over 100 other podcast outlets.

WEBVTT

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This program is designed to provide general information with regards

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to the subject matters covered. This information is given with

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the understanding that neither the hosts, guests, sponsors or station

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are engaged in rendering any specific and personal medical, financial, legal, counseling,

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professional service, or any advice.

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You should seek the services.

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Of confident professionals before applying or trying any suggested ideas.

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Books, PD, products, science, fashion and glam talk from Bollywood

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to Hollywood. It's Meet and Greet with Doctor Ashan Hashmi

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00:00:41.399 --> 00:00:44.399
right here on kate FURHD Radio and Talk for TV.

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And here's your host, international speaker, educator, award winning entrepreneur

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and best selling author, Doctor Ashan Hashmi.

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Hello everyone, this is your loving post Doctor of Shan

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Hashmi live from a studio in Rockville, Maryland, and today

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I am here at Hollywood Radio a live meet and

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read with Doctor of Shan Hashmi. And this show will

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be syndicated worldwide two three hundred million listeners. So, folks,

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if you want to give me sponsorship, please give me

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00:01:21.760 --> 00:01:27.359
sponsorship because in a very reasonable price, I will give

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you a sponsorship and you can contact me at Ashan

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at arrafshanhash MEI dot com. Having said that, folks, I

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just want to remind you that these are my two books.

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The first one is the Modern moven Mentality, New Strategies

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to succeed in India and the global marketplace. When this

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book came, there was a lot of result going on

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on Juguard and I have conceptualized Juguarde as thinking outside

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the box. The second one is The Outbreak of a

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Monstrous Infection. And when this book came, there was no

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COVID and in a very creative way, I have devised

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a story which shows that how bioterrorism can run the

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human population as COVID has done. And the best part

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is that COVID had not been introduced in the world

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when this book came. Having said and this book was

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Amazon bestseller, and this one was also Amazon bestseller, Modern

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mole Mentality with the hot number one new release on Amazon.

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And now, folks, I will I want a documentary to

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be made of this book, So all those documentary producers

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please contact me at Afshan at drrafshanhashme dot com. And

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for this Outbreak of a Monstrous Infection, I want a

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movie to be made. And tail Flix has given a

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very good evaluation of this, So please call go at

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my website Afshan www dot Shanhashmi dot com and see

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what you can get out of it. And having said that, folks,

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now you know I want now I want to like

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sponsorship for my show and I will ask my sound

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engineer Rebel to please play the sponsorship first film.

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Hello, viewers around the group.

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This is doctor Shan Hartman, a live.

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For her radio show at pay four SHB and talk

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for TV show and I just wanted to.

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Request you that wase give me a sponsorship if you

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want to.

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Want this show to continue.

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Having set that fence, I will see you in another.

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Episode of K four Strato.

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Plus for TV show And if you give.

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Me a sponsorship, I will give you very reasonable price

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and the also you will get a lot of promotion

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as this show is significated L right to move them

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thro will those cheers.

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And bu B.

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So, folks, now you know today's topic is like I

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will discuss a case study with a warning letter from FDA.

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I'm a regulatory affairs a specialist also, and I have

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a consulting company, Doctor Rashan Hashmi Consulting Growth. So if

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you have any of those needs, please contact me at

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Aughshan at drrafshanhame dot com and folks so from FTA

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page I got this and here it is development and

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approval process of drugs. Developing new drugs, American consumers benefit

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from having access to the saface and most advanced pharmaceutical

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system in the world. The main consumer watchdog in this

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system is FDA Center for Drug Evaluation and Research CDER.

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The center's best known job is to evaluate new drugs

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before they can be sold. CEDARS evaluation not only prevents poetry,

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but also provide doctors and patients the information they need

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to use medicines wisely. The center ensures that drug, both

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brand name and generic, work correctly and then help benefits

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outweigh their known drinks. Drug companies seeking to sell a

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drug in the United States but first tested the company

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then sets CEDAR the evidence from these tests to prove

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that drug is safe and effective for its intended use.

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A team of SEDAR physicians, statisaians, chemist pharmacologists, and other

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scientists reviews the company's data and propose labeling. If this

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independent and unvised review established that a drugs help benefits

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outweigh its known risks, the drug is approved for sale.

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The center doesn't actually does drugs itself, although it does

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contact limited research in the areas of drug quality, safety,

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and effectiveness standards. So, uh, folks, you know, the drug

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approval process is a very long process, and it was

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billions of dollars for a drug to come in the market.

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And the first of all, you know, like if if

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FDS says that this drug is not good for approval

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or if it is approved, they have to go and

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see the manufacturing facility. So I won't take the name

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of the company. There was a company announcement and it's

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say and usually companies, when when they see a problem,

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they voluntarily recall this drug. So is voluntary recalling the

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eye Drops product listed in the table below to the

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consume consumer level, with all lots within expiring with expiration

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dates ranging from November twenty twenty three to September twenty

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twenty five for all the below mentioned products. So there

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was this drug and you know they voluntarily recall it.

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Voluntarily recall means that you know, they thought that the

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drug is not up to the mark and they recalled it.

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So but you know, in India, and this drug was

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from India, a clinical trial outsourcing is a big game

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in India and big pharmaceutical companies from here are sourcing

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their clinical trials in India. And I have a big

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problem with that. You know, I have myself in my

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consulting company. I have gone to these CROs they are

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called clinical research outsourcing companies and they don't show their

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patient pool. They don't show their patient pool. And if

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they don't show their patient pool, it's very risky to

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see if a diabetes clinical I have seen a diabetes

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clinical trial like one person. You know, at the same

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time they're they're getting diabetes clinical trials, they are getting

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lots of other cancer clinical trials. The vass are used.

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So this is a big game in India. And the

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company I was auditing, I asked them that they never

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showed me the clinical trials outsourcing thing, that what is

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their patient pool? And there are a lot of manufacturing

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facilities in India. Let me go on a break and

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then I will come and talk about it.

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Would you love exposure for your business, product or service

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to over three hundred million potential listeners? Send an email

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to infoids talkform media dot com and now let's hear

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of the business fructilled Davenport.

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Hey, monstrous infection is spreading worldwide. OMG.

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Is this a simple infection or a deliberate attempt to

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ruin the human population? Or maybe it's bioterrorism. What is this.

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Global infection and who is spreading it?

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Help us find out? Go to Amazon and search for

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00:10:48.559 --> 00:10:52.720
the outbreak of a monstrous infection. The human race nature

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00:10:52.759 --> 00:10:55.799
helped to make this go viral. Go to Amazon dot

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00:10:55.840 --> 00:10:59.000
com and read the outbreak of a monstrous infection to

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find out what happened next. So now the world is

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depending on you.

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And now doctor ours on hashme's radio shows.

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So first Now. Clinical trial outsourcing in India has been

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a growing trend in recent years, driven by several factors,

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cost reduction, access to experience professionals, research and development promotion.

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Contract Research organization CROs are mushrooming across India, competing with

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each other to provide clinical trial services for pharmaceutical companies.

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US companies have been have even acquired Indian CROs to

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use as ups for their clinical research activity. How are

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The outsourcing of clinical trials to India has also been

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the subject of some controversy. Some have raised concerns that

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the outsourcing may not be relevant to the country's public

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health needs, and there have also been allegations of unethical conduct.

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Clinical trials in India continue to be in the news,

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unfortunately a fair bid being negative coverage. Over the last

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few years that has been continuing outrage on the issue

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of rising outsourcing clinical trials to India with concerns about

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little benefit or relevance to the public health needs of

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the country. And I was talking about this earlier. And

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the Drug Controller Journal of India grant's approval for clinical

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trials and is the top level authority when it specifically

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overseas clinical trials. The Drug Controller is a part of

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the Central Drug Standard Control Organization and answers to that

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western And I have seen that office and I'm sorry

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to say that it's not up to up to the mark.

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And even you see on the rooftop of that there

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are a lot of baboons and there are a lot

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of monkeys there and I don't know what like it

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is so dangerous, you know to go there. When I

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went there, I saw that. Now I don't know what

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the situation is. Okay, Submission of Ethics approval and DCGI approval,

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if applicable, is essanchell for trial registration in the CTRII.

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So multi country trials where India is a participating country

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which have been registered in an international registry are also

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expected to be registered in the CTRII Clinical Trials Registry India.

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And now I will go on a break and We'll

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be back soon.

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Would you love eposure for your business, product or service

190
00:14:02.039 --> 00:14:05.240
to over three hundred million potential listeners, send an email

191
00:14:05.279 --> 00:14:08.919
to info at talkformedia dot com. And now let's hear

192
00:14:08.960 --> 00:14:13.080
from some of our sponsors.

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A monstrous infection is spreading worldwide.

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Oh my god.

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00:14:27.879 --> 00:14:31.720
Is this a simple infection or a deliberate attempt to

196
00:14:31.799 --> 00:14:37.759
ruin the human population? Or maybe it's bioterrorism. What is

197
00:14:37.840 --> 00:14:41.320
this global infection and who is spreading it? Help us

198
00:14:41.360 --> 00:14:44.600
find out. Go to Amazon and search for the Outbreak

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00:14:44.679 --> 00:14:48.600
of a Monstrous Infection. These human race needs your help

200
00:14:48.679 --> 00:14:51.480
to make this go viral. Go to Amazon dot com

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00:14:51.519 --> 00:14:54.720
and read the Outbreak of a Monstrous Infection to find

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out what happens next.

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Go now, the world is depending on you.

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The Outbreak of a Monstrous Infection Chapter one, nineteen sixty

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four to twenty eighteen. And this is the sample track

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and it is read by doctor Rafshan Nahid Hashmi in

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a sprawling banglaw. In Potomac, Maryland, USA, lived doctor Honey Singh,

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a both certified internal medicine and family practice physician, along

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with his beautiful wife, Baby Singh. Baby Singh was a

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fashionista and was funding women's causes through her Honeybay Foundation.

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She had a lady's book club by the name of

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Baby's Clam and Glitzy Club, which had many clam and

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Glitzy ladies who were professionals living in Washington, DC, Potomac, Maryland, Virginia,

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and even Beverly Hills, California, as well as a lead

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from all of America, meeting at her place on the

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00:16:04.720 --> 00:16:09.799
last Wednesday of every month discussing various aspects of charities

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00:16:10.039 --> 00:16:13.960
they wanted her and doctor Honey to fund. In this club,

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there was a wide spectrum of career women. There were doctors, lawyers, actresses,

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business owners, and models to name a few. In these

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book club meetings, members would come prepared after reading a

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book of a famous woman author and that author was

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even invited from any part of the world to give

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her presentation, followed by a q anda in this prestigious

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and elite gathering.

225
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And now thanks to doctor Ashan Hashmi's radio shows.

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The Indian pharmaceutical industries projected to grow at a cger

227
00:16:59.799 --> 00:17:03.080
of over ten percent to reach a size of US

228
00:17:03.120 --> 00:17:07.319
dollars one thirty billion by twenty thirty. India has emerged

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as the medical tourism hub of the world, providing cost

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effective treatments with the latest technology, enabled by several power

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breaking reforms and provisions. Access to affordable CHIV treatment from

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India is one of the greatest success stories in medicine.

233
00:17:23.079 --> 00:17:25.839
India is one of the biggest suppliers of low cost

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00:17:25.960 --> 00:17:28.880
vaccines in the world. Because of the low price and

235
00:17:28.960 --> 00:17:33.559
high quality, Indian medicines are preferred worldwide, thereby rightly making

236
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the country the pharmacy of the world. India has been

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traditionally quite strong in the pharma sector, with a low

238
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cost of manufacturing thirty percent to thirty five percent lower

239
00:17:44.559 --> 00:17:47.480
than the US and Europe, cost efficient R and D

240
00:17:47.640 --> 00:17:51.200
about eighty seven percent less than the develop market and

241
00:17:51.359 --> 00:17:56.519
keep skill labor. On December twenty one, twenty two, MoU

242
00:17:56.720 --> 00:18:00.000
was signed between Tata Memorial Center of India and Wetness

243
00:18:00.119 --> 00:18:03.960
Armed National Cancer Center to a cancer hospital to promote

244
00:18:04.039 --> 00:18:08.759
exchanges in the areas of training and scientific healthcare services,

245
00:18:08.799 --> 00:18:13.079
collaboration in diagnosis and treatment for cancer patients, the treatment

246
00:18:13.160 --> 00:18:16.240
for cancer patients. The total market size of the Indian

247
00:18:16.279 --> 00:18:20.160
farmer industry is expected to reach US dollars one thirty

248
00:18:20.200 --> 00:18:25.240
billion by twenty thirty and US dollar four fifty billion

249
00:18:25.319 --> 00:18:29.880
market by twenty forty seven. The domestic pharmaceutical industry would

250
00:18:30.039 --> 00:18:33.400
likely reach US dollar fifty seven billion by f y

251
00:18:33.519 --> 00:18:36.599
twenty five and see an increase in operating margins of

252
00:18:36.599 --> 00:18:40.279
one hundred to one fifty basis point pps. India has

253
00:18:40.319 --> 00:18:45.200
the largest number of USFDA compliant pharmaceutical plants outside the

254
00:18:45.319 --> 00:18:49.400
US and over two thousand who GMP approved festival Tea

255
00:18:49.519 --> 00:18:54.079
serving demand from one fifty plus countries worldwide, with ten thousand,

256
00:18:54.200 --> 00:18:58.279
five hundred plus manufacturing facility. So the warning letter I

257
00:18:58.359 --> 00:19:03.759
have taken around disclose the company is of the warning

258
00:19:03.839 --> 00:19:08.039
letter they got from Issuing Office Center for Drug Evaluation

259
00:19:08.559 --> 00:19:12.079
and Research SED the United States, and it says the

260
00:19:12.240 --> 00:19:16.319
US Food and Drug Administration since there are so many

261
00:19:16.400 --> 00:19:22.440
manufacturing facilities and people outsource that for cost efficiency. But

262
00:19:22.640 --> 00:19:26.119
I am not very very happy with the what I

263
00:19:26.200 --> 00:19:30.640
read here and the cost is uh uh. I know

264
00:19:30.799 --> 00:19:34.759
cost is lower than US, but there you know, the

265
00:19:34.759 --> 00:19:38.759
manufacturing facilities are not up to the mark. I have

266
00:19:38.880 --> 00:19:43.119
seen clinical trial outsourcing. I haven't seen the manufacturing facility

267
00:19:43.200 --> 00:19:46.039
in India. But you know, this is a very depressing,

268
00:19:46.240 --> 00:19:50.480
depressing thing about India. So companies who are outsourcing in

269
00:19:51.200 --> 00:19:58.640
UH the India UH should should pay attention that if

270
00:19:58.799 --> 00:20:03.000
if a drug is approved in America, then it should

271
00:20:03.319 --> 00:20:07.839
it should have been very very efficient process and very

272
00:20:07.960 --> 00:20:14.279
very like clean process, you know, and cGMP. Sure, and

273
00:20:14.359 --> 00:20:19.519
I have worked on cGMP and like in a manufacturing

274
00:20:19.599 --> 00:20:24.079
facility and in quality control. So it has to be

275
00:20:24.240 --> 00:20:29.000
up to the mark. And see it says the US

276
00:20:29.039 --> 00:20:33.880
Food and Drug Administration FDA inspected your drug manufacturing facility.

277
00:20:35.319 --> 00:20:40.920
This forming letters summarizes significant violations of current Code Manufacturing

278
00:20:41.000 --> 00:20:47.119
Practice c GMP regulations for Finnish mceuticals see Title twenty

279
00:20:47.160 --> 00:20:51.519
one Code of Federal Regulations CFR Part two twenty and

280
00:20:51.559 --> 00:20:57.400
two eleven twenty one CFR Part two ten and two eleven.

281
00:21:04.240 --> 00:21:10.880
And now of your friends, let me go. Because your method, facility,

282
00:21:11.079 --> 00:21:15.440
or controls for manufacturing, processing, packing, or holding do not

283
00:21:15.680 --> 00:21:21.400
conform to c GMP. Your drug products are adulterated within

284
00:21:21.480 --> 00:21:24.640
the meaning of section five oh one A two B

285
00:21:24.960 --> 00:21:30.000
of the Federal Food, Drug and Cosmetic app FDNCF T

286
00:21:30.240 --> 00:21:35.079
L fewer USC three five one A two B because

287
00:21:35.160 --> 00:21:40.400
your drug products were prepared, packed, or held under insanitary

288
00:21:40.480 --> 00:21:45.000
conditions whereby they may have become contaminated with filth or

289
00:21:45.079 --> 00:21:49.519
rendered Injuryers to help your drug products are also deliberated

290
00:21:49.599 --> 00:21:53.119
within the meaning of section FIVEH one A two A

291
00:21:53.440 --> 00:21:57.160
of the fdn C At twenty one USC three five

292
00:21:57.559 --> 00:22:00.960
one A two A, we review t or November ten,

293
00:22:01.039 --> 00:22:04.920
twenty three response to our form FDA four eighty three

294
00:22:05.279 --> 00:22:11.279
in detail and acknowledge received of your subsequent correspondence so

295
00:22:11.440 --> 00:22:14.839
FDA four eighty three is the warning letter which is

296
00:22:14.839 --> 00:22:22.200
issued by FDA. During our inspection, our investigators absorbed specific violations, including,

297
00:22:22.559 --> 00:22:27.559
but not limited to, the following conditions and in sanitary conditions.

298
00:22:27.599 --> 00:22:31.839
Your drug products are adulterated under section five oh one

299
00:22:32.039 --> 00:22:37.440
A two A of the FBCC because they were prepared, packed,

300
00:22:37.519 --> 00:22:46.119
or held under insanitary conditions. FDA investigators observed your facility

301
00:22:46.240 --> 00:22:50.119
to be in a state of despair, poorly cleaned and

302
00:22:50.240 --> 00:22:53.720
maintained it as evidenced by B four residue on the

303
00:22:53.799 --> 00:22:57.720
B four adjacent to the HIPPA filters in the ISO

304
00:22:57.839 --> 00:23:03.440
five area. Multiple barefoot employees in ISO it area without

305
00:23:03.519 --> 00:23:08.440
required gowning, including gloves, while handling materials being transferred into

306
00:23:08.519 --> 00:23:14.559
the ISO seven manufacturing area operators use visibly dirty restricted

307
00:23:14.720 --> 00:23:19.599
access barrier system wraps before for interventions on the filling line,

308
00:23:19.759 --> 00:23:23.720
your response is not adequate. While you commit to replacing

309
00:23:23.799 --> 00:23:27.960
the bfore that surround the HIPPA filtration system, your response

310
00:23:28.039 --> 00:23:31.319
does not include an evaluation of the resudue on the

311
00:23:31.400 --> 00:23:36.119
B four to determine its identity or investigate the source.

312
00:23:37.160 --> 00:23:42.079
You also commit to perform retraining personal for gowning requirements

313
00:23:42.079 --> 00:23:47.200
and implement procedure for stralization of wraps before. However, you

314
00:23:47.319 --> 00:23:53.559
do not evaluate the micro microbiological impact that lack of

315
00:23:53.680 --> 00:23:58.119
proper gowning and in uncleaned wraps before has on your

316
00:23:58.160 --> 00:24:02.960
classified area such as ISO five, ISO seven, and ISO eight.

317
00:24:03.240 --> 00:24:07.799
The potential impact to spalde drug products produced under these

318
00:24:07.880 --> 00:24:11.839
insanitary conditions is also not addressed. So now I will

319
00:24:11.880 --> 00:24:14.079
go on a break and we'll be back soon.

320
00:24:17.200 --> 00:24:19.920
Would you love exposure for your business, product or service

321
00:24:20.000 --> 00:24:23.119
to over three hundred million potential listeners? Send an email

322
00:24:23.200 --> 00:24:26.839
to infots talkform media dot com and now let's hear

323
00:24:26.880 --> 00:24:33.839
from some of our sponsors.

324
00:24:38.759 --> 00:24:44.599
Chapter two, How jugar leads to multisector seccess stories in India,

325
00:24:44.720 --> 00:24:49.680
including definitions of the JUGAR management, principal business model of

326
00:24:49.920 --> 00:24:54.599
the book The Modern Mobile Mentality, News strategies to succeed

327
00:24:54.720 --> 00:24:59.839
in India and the global marketplace, inspiration through jugar is,

328
00:25:00.079 --> 00:25:04.599
and inspiration on how to create products using technology that

329
00:25:04.759 --> 00:25:09.200
meet the price value equation. According to a Harvard Business

330
00:25:09.279 --> 00:25:15.400
Review article featuring expert prellad Than Marshalcare, most innovation programs

331
00:25:15.400 --> 00:25:19.319
are built on the assumptions of affluence and abundance. We

332
00:25:19.400 --> 00:25:22.079
see the rich and the young in both the developed

333
00:25:22.119 --> 00:25:27.720
and the developing countries demanding environmental friendly products and services.

334
00:25:27.759 --> 00:25:33.079
They also believe that affordability and sustainability are crucial to

335
00:25:33.240 --> 00:25:39.240
driving successful business today. New technologies and radical business models

336
00:25:39.279 --> 00:25:43.559
are important not only to penefit mass markets in India

337
00:25:43.599 --> 00:25:48.440
but in the entire world. By reconfigure during all areas

338
00:25:48.480 --> 00:25:50.519
of the business structure, they will.

339
00:25:50.359 --> 00:26:07.920
Hold Hey, monstrous infection is spreading worldwide. OMG.

340
00:26:08.519 --> 00:26:12.079
Is this a simple infection or a deliberate attempt to

341
00:26:12.240 --> 00:26:17.519
ruin the human population, or maybe it's bio terrorism. What

342
00:26:17.680 --> 00:26:20.799
is this global infection and who is spreading it? Help

343
00:26:20.880 --> 00:26:24.200
us find out? Go to Amazon and search for the

344
00:26:24.240 --> 00:26:26.440
outbreak of a monstrous infection.

345
00:26:27.039 --> 00:26:27.759
The human race.

346
00:26:27.839 --> 00:26:31.000
Nature helped to make this go viral, go to Amazon

347
00:26:31.039 --> 00:26:34.200
dot com and read the Outbreak of a Monstrous Infection

348
00:26:34.359 --> 00:26:38.039
to find out what happens next. Go now the world

349
00:26:38.200 --> 00:26:44.240
is depending on you.

350
00:26:51.799 --> 00:26:54.880
And now back to Doctor Offshan Hashmis radio show.

351
00:27:01.720 --> 00:27:07.319
So Firth, Now, I want to say that you know

352
00:27:07.440 --> 00:27:10.039
it should be America first. You know, it should not

353
00:27:10.319 --> 00:27:17.440
be like I know, the manufacturing facilities are less expensive

354
00:27:17.480 --> 00:27:21.960
in India, but look at look at this warning letter example,

355
00:27:22.319 --> 00:27:26.880
how how poor quality it's an opthalmic product. Uh product

356
00:27:26.960 --> 00:27:29.079
you put it in your eye and the way it

357
00:27:29.119 --> 00:27:31.839
has been done, you know, and there are many many

358
00:27:31.880 --> 00:27:37.119
problems you know in manufacturing facilities in India and here.

359
00:27:37.279 --> 00:27:42.559
If we make drugs or products here, drug products or

360
00:27:42.599 --> 00:27:45.880
medical devices products here, you know, there will be so

361
00:27:46.000 --> 00:27:49.279
much jobs for America. And I see I am without

362
00:27:49.720 --> 00:27:52.200
without a job. You know, I do this show. If

363
00:27:52.240 --> 00:27:56.359
I get a sponsorship, you know I will get a sponsorship.

364
00:27:56.400 --> 00:27:59.920
It is very hard, you know, to sustain these kinds

365
00:27:59.920 --> 00:28:02.960
of shows without a sponsorship. So this show will be

366
00:28:03.039 --> 00:28:07.599
syndicated worldwide two three hundred million listeners. So please give

367
00:28:07.640 --> 00:28:12.480
me a sponsorship, and now let me see and see

368
00:28:12.519 --> 00:28:16.720
the quality of the work. It says c GMP violation.

369
00:28:17.160 --> 00:28:21.680
Your firm failed to establish and follow appropriate written procedures

370
00:28:21.720 --> 00:28:27.240
that are designed to prevent microbiological contamination of drugs products

371
00:28:27.279 --> 00:28:31.720
computing to be sterile, and that include validation of all

372
00:28:31.839 --> 00:28:38.599
acceptic and asterilization processes. Poor practices in the accepting processing areas.

373
00:28:38.640 --> 00:28:43.240
In addition to the insanitary conditions described above, during the

374
00:28:43.319 --> 00:28:48.319
inspection of your facility, we observe poor practices and behaviors

375
00:28:48.359 --> 00:28:52.319
in ISO five areas during the manufacturing of a sterile

376
00:28:52.440 --> 00:28:56.759
drug products. These poor practices included, but are not limited to,

377
00:28:56.839 --> 00:29:01.279
operators performing interventions on the filling line in ISO five

378
00:29:01.319 --> 00:29:04.160
areas using a plot to wipe the B four of

379
00:29:04.240 --> 00:29:09.599
the filling B four and the conveyer operators leaning over

380
00:29:09.720 --> 00:29:13.559
the filling line, including open and filled eye drop bottles

381
00:29:13.599 --> 00:29:18.839
blocking unidirectional airflow, operators in the ISO five area not

382
00:29:19.039 --> 00:29:22.960
wearing goggles and therefore had exposed a skin during line

383
00:29:23.000 --> 00:29:27.720
set up, and ACCEPTIC processing operators observe placing bags of

384
00:29:27.880 --> 00:29:31.119
component that made contact with the walls in the ISO

385
00:29:31.200 --> 00:29:34.960
seven area into the ISO five area without the bags

386
00:29:34.960 --> 00:29:40.880
being disinfected. So if FDA is manufacturing, If FDA is

387
00:29:41.160 --> 00:29:46.440
doing inspection. So that means you know, the manufacturer had

388
00:29:46.519 --> 00:29:50.160
plans to bring the drug to US market or they

389
00:29:50.240 --> 00:29:52.759
want to make there are two things. They want to

390
00:29:52.839 --> 00:29:59.400
make FDA compliant facility so that they can get more

391
00:29:59.480 --> 00:30:04.119
projects from US and other countries which which believe that

392
00:30:04.359 --> 00:30:09.599
FDA has the highest level you know of uh like

393
00:30:09.799 --> 00:30:13.839
the highest level of regulations, so they can make FDA

394
00:30:14.000 --> 00:30:20.920
compliant facility to advertise it that they have FDA compliant facility.

395
00:30:21.000 --> 00:30:24.599
Now this is an FDA compliant facility. But see how

396
00:30:24.720 --> 00:30:29.480
much problems they have. So so I think you know it.

397
00:30:29.599 --> 00:30:34.359
The best is to have manufacturing facilities in America where

398
00:30:34.440 --> 00:30:38.559
people can you know, have jobs. Having set that forth,

399
00:30:38.680 --> 00:30:41.559
now I will go on a break and will be

400
00:30:41.680 --> 00:30:42.480
back soon.

401
00:30:44.599 --> 00:30:56.599
Earlier around the right and top for in friends, I

402
00:30:56.759 --> 00:31:00.000
am never in a country.

403
00:31:00.160 --> 00:31:00.720
And just.

404
00:31:07.640 --> 00:31:12.799
Go on money to produce these.

405
00:31:14.240 --> 00:31:15.119
Having sept the.

406
00:31:16.880 --> 00:31:28.480
Partnership, actual and say inadequate smoke studies. Smoke studies performed

407
00:31:28.519 --> 00:31:32.799
by your firm are not adequate to show unidirectional airflow

408
00:31:32.920 --> 00:31:38.039
in the acceptic processing areas. Multiple instances of turbulent airflow

409
00:31:38.079 --> 00:31:41.799
in critical areas of the B four filling line were noted,

410
00:31:41.880 --> 00:31:46.160
including above the filling before. In addition, smoke study videos

411
00:31:46.200 --> 00:31:49.839
did not include setup of the aceptic processing line or

412
00:31:49.960 --> 00:31:55.240
interventions of the filling line that stimulate actual manufacturing. There

413
00:31:55.319 --> 00:31:58.880
is so much a problem in this manufacturing site. Your

414
00:31:58.960 --> 00:32:03.519
firm failed to ensure the laboratory records, including complete data

415
00:32:03.599 --> 00:32:09.119
derived all test necessary to ensure compliance which established specifications

416
00:32:09.160 --> 00:32:13.759
and Standard twenty one CFI two eleven point one ninety

417
00:32:13.799 --> 00:32:17.279
four A. Your firm failed to collect the required amount

418
00:32:17.400 --> 00:32:22.279
of environmental and personal monitoring samples required by your procedures

419
00:32:22.319 --> 00:32:26.960
to support the manufacture of a sterile products during the inspection.

420
00:32:27.160 --> 00:32:33.000
A reconcili consaliation of samples that should have been taken

421
00:32:33.119 --> 00:32:37.599
during manufacturing activities and those that were actually taken did

422
00:32:37.640 --> 00:32:43.119
not match. Interviews with microbiology laboratory staff and management confirmed

423
00:32:43.119 --> 00:32:46.480
that it is your routine practice to fabricate results for

424
00:32:46.559 --> 00:32:50.240
samples that were never taken or to alter results for

425
00:32:50.319 --> 00:32:54.720
samples that would otherwise fail to meet establish a specification

426
00:32:55.960 --> 00:33:01.000
that record information for environmental monitoring is not recorded at

427
00:33:01.039 --> 00:33:04.720
the time of completion. For example, a badge record was

428
00:33:04.759 --> 00:33:08.799
being filled out in the microbiology laboratory on October twelve,

429
00:33:08.799 --> 00:33:12.880
twenty twenty three, for bat B four that was manufactured

430
00:33:13.200 --> 00:33:17.400
in March twenty twenty three, approximately six months prior to

431
00:33:17.480 --> 00:33:21.440
the recorded date. Data of the microbil activity in the

432
00:33:21.480 --> 00:33:25.400
filtration slack filling area in the batche record was blank

433
00:33:25.519 --> 00:33:30.000
on October twelve, twenty twenty three. This includes the air

434
00:33:30.119 --> 00:33:34.240
sample and non viable particulate counting, start and end time

435
00:33:34.319 --> 00:33:38.960
activity done by signatures and dates and checked by signatures

436
00:33:39.000 --> 00:33:43.039
on date when the record was later provided on October nineteen,

437
00:33:43.119 --> 00:33:46.680
twenty twenty three, the record was filled out with time,

438
00:33:46.799 --> 00:33:51.759
signatures and dates in March twenty twenty three. Laboratory technicians,

439
00:33:51.839 --> 00:33:56.960
now this is very important. Laboratory techians falsified this data

440
00:33:57.000 --> 00:34:00.920
which is critical to maintaining in ongoing day of control

441
00:34:00.960 --> 00:34:05.160
in your septic processing facilities. So data was made up.

442
00:34:05.480 --> 00:34:11.519
How cruel this is. So, I think my recommendation would

443
00:34:11.519 --> 00:34:16.599
be that even if the cost is high, the manufacturing

444
00:34:16.639 --> 00:34:20.519
facility should be in America and it should not be

445
00:34:21.159 --> 00:34:25.679
outsourced to India to these kind of manufacturing facilities. Having

446
00:34:25.760 --> 00:34:28.559
said that, folks, now I will go on a break

447
00:34:28.599 --> 00:34:29.760
and will be back soon.

448
00:34:32.480 --> 00:34:35.199
Would you love exposure for your business, product or service

449
00:34:35.239 --> 00:34:38.440
to over three hundred million potential listeners send an email

450
00:34:38.480 --> 00:34:42.119
to infots talkform media dot com and now let's hear

451
00:34:42.159 --> 00:34:47.719
from some of our sponsors.

452
00:34:54.039 --> 00:34:59.760
Chapter two, How Jugar leads to multisector success stories in India,

453
00:35:00.079 --> 00:35:04.960
including definitions of the Jugar management, principal business model of

454
00:35:05.199 --> 00:35:09.880
the book, the modern Mobile mentality, news strategies to succeed

455
00:35:10.039 --> 00:35:15.239
in India and the global marketplace. Inspiration through Jugar is

456
00:35:15.280 --> 00:35:19.880
an inspiration on how to create products using technology that

457
00:35:20.039 --> 00:35:24.480
meet the price value equation. According to a Harvard Business

458
00:35:24.559 --> 00:35:30.679
Review article featuring expert prellad Than marshalcre most innovation programs

459
00:35:30.679 --> 00:35:34.599
are built on the assumptions of affluence and abundance. We

460
00:35:34.679 --> 00:35:37.360
see the rich and the young in both the developed

461
00:35:37.400 --> 00:35:43.000
and the developing countries demanding environmental friendly products and services.

462
00:35:43.039 --> 00:35:48.360
They also believe that affordability and sustainability are crucial to

463
00:35:48.519 --> 00:35:54.519
driving successful business Today. New technologies and radical business models

464
00:35:54.559 --> 00:35:58.840
are important not only to benefit mass markets in India,

465
00:35:58.880 --> 00:36:03.039
but in the entire way by re consi during all

466
00:36:03.159 --> 00:36:05.559
areas of the business structure they're in.

467
00:36:05.639 --> 00:36:24.239
For Hey, monstrous infection is spreading worldwide? OMG. Is this

468
00:36:24.320 --> 00:36:27.960
a simple infection or a deliberate attempt to ruin the

469
00:36:28.039 --> 00:36:32.360
human population, or maybe it's bioterrorism.

470
00:36:32.719 --> 00:36:33.239
What is this.

471
00:36:33.239 --> 00:36:36.840
Global infection and who is spreading it? Help us find out.

472
00:36:37.159 --> 00:36:40.679
Go to Amazon and search for the outbreak of a

473
00:36:40.760 --> 00:36:44.199
monstrous infection. The human race nature helped to make this

474
00:36:44.320 --> 00:36:47.840
go viral. Go to Amazon dot com and read the

475
00:36:47.880 --> 00:36:51.159
outbreak of a monstrous infection to find out what happens next.

476
00:36:51.679 --> 00:37:04.599
Go now the world is depending on you.

477
00:37:07.079 --> 00:37:12.360
And now doctor Ops on Hashmes radio show.

478
00:37:17.199 --> 00:37:22.199
So now this is data integrity remediation. Your quality system

479
00:37:22.320 --> 00:37:27.559
does not adequately ensure the accuracy and integrity of data

480
00:37:27.679 --> 00:37:32.280
to support the safety, effects, fiveness, and quality of the

481
00:37:32.360 --> 00:37:37.639
drugs you manufacture. C FDS Guidance Document Data Integrity and

482
00:37:37.760 --> 00:37:42.719
Compliance with Drugs cGMP for guidance on establishing and following

483
00:37:42.840 --> 00:37:50.400
cGMP compliant data integrity practices at STT based slash flash

484
00:37:50.559 --> 00:37:55.360
www dot FDA dot gov slash Media one one, nine, two, six,

485
00:37:55.440 --> 00:37:59.360
seventh SLADE download. We acknowledge that you are using an

486
00:37:59.400 --> 00:38:04.079
independent then third party consultant to audit your operation and

487
00:38:04.280 --> 00:38:08.599
assist in meeting a FDA requirement. In response to this letter,

488
00:38:08.800 --> 00:38:14.800
provide a comprehensive investigation into the extent of the inaccuracies

489
00:38:14.840 --> 00:38:19.280
in data records and reporting. Your investigation should include a

490
00:38:19.400 --> 00:38:26.360
detailed investigation protocol and methodology, summary of all laboratories, manufacturing

491
00:38:26.480 --> 00:38:30.400
operations and systems to be covered by the assessment, and

492
00:38:30.480 --> 00:38:34.320
a justification for any part of your operation that you

493
00:38:34.480 --> 00:38:38.599
propose to exclude. Interviews of current and former employees to

494
00:38:38.719 --> 00:38:42.960
identify the nature, scope and root cause of data. Now,

495
00:38:43.079 --> 00:38:48.079
every data in accuracies here, I will say that every

496
00:38:48.199 --> 00:38:52.639
term tick and carry wants to make quick money. And

497
00:38:52.960 --> 00:38:56.440
this is a very very serious thing that they are

498
00:38:56.559 --> 00:39:00.960
making data, you know, And I'm so disturbed to see

499
00:39:00.960 --> 00:39:04.719
this and what kind of consultant was auditing this that

500
00:39:04.840 --> 00:39:07.960
they did not help them in that. So the best

501
00:39:07.960 --> 00:39:12.639
thing is not to outsources to these kind of manufacturing

502
00:39:12.679 --> 00:39:16.639
facilities which say they are FDA compliant but are not

503
00:39:16.840 --> 00:39:19.679
doing a good job. So the best way is to

504
00:39:19.800 --> 00:39:25.559
have a manufacturing facility in US, FDA compliant manufacturing facility

505
00:39:25.679 --> 00:39:29.679
in US and produce your drugs here in US only.

506
00:39:30.119 --> 00:39:33.800
That is the best thing because in clinical trial outsourcing,

507
00:39:34.199 --> 00:39:38.039
I had a very bad experience. I saw that you know,

508
00:39:38.719 --> 00:39:41.840
the company, the CROs, you know, they don't show their

509
00:39:41.880 --> 00:39:45.119
patient pool. And I have even put this up at

510
00:39:45.199 --> 00:39:49.679
Regulatory Affairs Professional Society a meeting, and I asked that

511
00:39:49.920 --> 00:39:53.599
questions to Big pharmas over here their executives were in

512
00:39:53.639 --> 00:39:57.440
the panel. They did not answer to me directly, and

513
00:39:58.239 --> 00:40:02.599
that means there is a problem. Having said that, we

514
00:40:02.800 --> 00:40:07.679
recommend that these interviews be conducted by a qualified third party.

515
00:40:08.079 --> 00:40:13.480
An assessment of the extent of data integrity definition deficiencies

516
00:40:13.519 --> 00:40:20.320
at your facility. Identify omissions, alterations, deletions, record restruction, non

517
00:40:20.400 --> 00:40:27.000
contempoerinious record completion and other deficiencies. Describe all parts of

518
00:40:27.039 --> 00:40:32.360
your facilities operations in which you discover data integrity lapses.

519
00:40:32.639 --> 00:40:37.480
A comprehensive retrospective evaluation of the nature of the testing

520
00:40:37.559 --> 00:40:42.760
data integrity deficiencies. We recommend that a qualified third party

521
00:40:43.000 --> 00:40:48.400
with specific expertise in the area where potential breaches where identified,

522
00:40:48.519 --> 00:40:53.719
should evaluate all data integrity lapses. A current risk assessment

523
00:40:53.840 --> 00:40:57.360
of the potential effects of the observed failures on the

524
00:40:57.440 --> 00:41:03.239
quality of your drugs. Your assessment should include analysis of

525
00:41:03.320 --> 00:41:06.760
the risk to patients caused by the release of drugs

526
00:41:06.800 --> 00:41:11.840
affected by a lapse of data integrity, and analysis of

527
00:41:12.039 --> 00:41:16.920
the risk posed by ongoing operations. A management strategy for

528
00:41:17.119 --> 00:41:20.599
your firm that includes the details of your global cape

529
00:41:20.639 --> 00:41:24.639
A plan. Your study should include at a detailed corrective

530
00:41:24.679 --> 00:41:28.480
action plan that describes how you intend to ensure the

531
00:41:28.599 --> 00:41:34.199
reliability and completeness of all data you generate, including analytical data,

532
00:41:34.559 --> 00:41:39.559
manufacturing records, and all data submitted to FDA. A comprehensive

533
00:41:39.639 --> 00:41:43.559
descruption of the root causes of your data integrity lapses,

534
00:41:43.639 --> 00:41:47.119
including evidence that the scope and depth of the current

535
00:41:47.199 --> 00:41:51.719
plan should is commensurate with the findings of the investigation

536
00:41:51.960 --> 00:41:56.639
and risk assessment. Indicate whether individual is responsible for data

537
00:41:56.639 --> 00:42:01.519
integrity lapses remain able to influence SEGEMP related or drug

538
00:42:01.559 --> 00:42:06.360
application data at your form and the regulatory affairs professional

539
00:42:06.440 --> 00:42:10.599
there is responsible in the company is responsible to see that,

540
00:42:10.880 --> 00:42:15.119
or if they hired somebody else as a consultant, that

541
00:42:15.239 --> 00:42:20.639
person is responsible. But ultimately the thing comes on the

542
00:42:20.639 --> 00:42:24.159
CEO of the company. So the CEOs of the company

543
00:42:24.199 --> 00:42:29.639
should be very very very They should see who their

544
00:42:29.639 --> 00:42:34.159
regulatory affairs specialist is and what his or her qualification

545
00:42:34.559 --> 00:42:37.920
is so that these kinds of things are not happening,

546
00:42:37.960 --> 00:42:44.840
and whether their expertise in manufacturing in inspection of manufacturing facilities.

547
00:42:45.480 --> 00:42:48.960
Having said that, folks, you know now the time is

548
00:42:49.039 --> 00:42:54.880
getting uh. So these are my two books. The first

549
00:42:54.920 --> 00:42:58.400
one is The Outbreak of a Monster's Infection and the

550
00:42:58.760 --> 00:43:02.239
sec and the and this book. The second one is

551
00:43:02.239 --> 00:43:06.920
The Modern Mobal Mentality news strategies to succeed in India

552
00:43:06.960 --> 00:43:10.400
and the global marketplace. So when this book came, the

553
00:43:10.480 --> 00:43:13.800
Modern Local Mentality was my first book, there was a

554
00:43:13.800 --> 00:43:17.719
lot of research going on. Juguar and I have conceptualized

555
00:43:17.760 --> 00:43:21.239
ju guard as thinking outside the box and the and

556
00:43:21.599 --> 00:43:24.840
I want a documentary to be made and many American

557
00:43:24.960 --> 00:43:28.320
and global companies are in this. So please go and

558
00:43:28.360 --> 00:43:32.679
buy this book. And please all those documentary producers please

559
00:43:32.719 --> 00:43:36.760
contact me at a Shan at trshan archme dot com.

560
00:43:36.800 --> 00:43:40.280
This will be a very good project for a documentary film.

561
00:43:40.400 --> 00:43:43.840
The second one the Outbreak of a Monstrous Infection. I

562
00:43:43.960 --> 00:43:46.519
want a movie to be made or a web series

563
00:43:46.639 --> 00:43:49.559
or a TV serial and tail Flix has given me

564
00:43:49.639 --> 00:43:53.760
a very very good evaluation of this and this was

565
00:43:54.079 --> 00:43:58.519
Outbreak of a Monster's Infection was Amazon bestseller as well

566
00:43:58.559 --> 00:44:03.719
as this one. Modern Moble Mentality was Amazon bestseller and

567
00:44:03.800 --> 00:44:08.480
hot number one new release on Amazon. Having set that, folks,

568
00:44:09.519 --> 00:44:15.199
now I will say cheers and bye bye, and the

569
00:44:15.239 --> 00:44:19.199
remaining of the time, Rebel my sound engineer will play

570
00:44:20.239 --> 00:44:25.360
another commercial. And this show is syndicated worldwide to three

571
00:44:25.440 --> 00:44:29.039
hundred million listeners. So if you give me sponsorship, it

572
00:44:29.079 --> 00:44:32.360
would be great, because to sustain these kind of shows,

573
00:44:32.400 --> 00:44:35.760
it's very difficult. It make a You have to spend

574
00:44:35.719 --> 00:44:38.599
a lot of money to sustain these kind of shows.

575
00:44:38.800 --> 00:44:41.679
And I want a sponsorship to make money for me

576
00:44:41.840 --> 00:44:46.480
because these books, you know, these two books, and sponsorships

577
00:44:46.639 --> 00:44:50.639
bring food to that table. Having set that folks, cheers

578
00:44:51.039 --> 00:44:53.760
and bye bye.

579
00:44:54.880 --> 00:44:57.599
Would you love exposure for your business, product or service

580
00:44:57.679 --> 00:45:00.800
to over three hundred million potential listeners. Send an email

581
00:45:00.920 --> 00:45:04.559
to info at talkformedia dot com and now let's hear

582
00:45:04.559 --> 00:45:11.519
from some of our sponsors.

583
00:45:18.559 --> 00:45:21.719
A monstrous infection is spreading worldwide.

584
00:45:22.519 --> 00:45:25.760
Oh my god. Is this a simple infection or a

585
00:45:25.880 --> 00:45:28.079
deliberate attempt to ruin.

586
00:45:27.880 --> 00:45:33.639
The human population, or maybe it's bioterrorism. What is this

587
00:45:33.760 --> 00:45:37.480
global infection and who is spreading it? Help us find out.

588
00:45:37.679 --> 00:45:40.559
Go to Amazon and search for the outbreak of a

589
00:45:40.800 --> 00:45:42.079
monstrous infection.

590
00:45:42.599 --> 00:45:45.440
These human race needs your help to make this go viral.

591
00:45:45.760 --> 00:45:48.679
Go to Amazon dot com and read the Outbreak of

592
00:45:48.719 --> 00:45:53.000
a Monstrous Infection. To find out what happens next. Go now,

593
00:45:53.519 --> 00:45:55.320
the world is depending on you.

594
00:46:06.159 --> 00:46:11.400
The Outbreak of a Monstrous Infection Chapter one, nineteen sixty

595
00:46:11.440 --> 00:46:15.079
four to twenty eighteen. And this is the sample track

596
00:46:15.639 --> 00:46:19.519
and it is read by doctor Rafshan Nahi Hashmi in

597
00:46:19.599 --> 00:46:24.920
a sprawling banglaw. In Potomac, Maryland, USA, lived doctor Honey Singh,

598
00:46:24.960 --> 00:46:30.039
a both certified internal medicine and family practice physician, along

599
00:46:30.119 --> 00:46:33.599
with his beautiful wife, Baby Singh. Baby Singh was a

600
00:46:33.639 --> 00:46:38.320
fashionista and was funding women's causes through her Honeybay Foundation.

601
00:46:38.880 --> 00:46:41.639
She had a lady's book club by the name of

602
00:46:41.760 --> 00:46:45.400
Baby's Clam and Glitzy Club, which had many clam and

603
00:46:45.480 --> 00:46:51.880
Glitzy ladies who were professionals living in Washington, DC, Potomac, Maryland, Virginia,

604
00:46:51.920 --> 00:46:55.960
and even Beverly Hills, California, as well as a lead

605
00:46:56.079 --> 00:46:59.360
from all of America, meeting at her place on the

606
00:46:59.440 --> 00:47:04.519
last Wensday of every month discussing various aspects of charities

607
00:47:04.800 --> 00:47:08.719
they wanted her and doctor Honey to fund. In this club,

608
00:47:08.800 --> 00:47:14.239
there was a wide spectrum of career women. There were doctors, lawyers, actresses,

609
00:47:14.360 --> 00:47:17.960
business owners, and models. To name a few. In these

610
00:47:17.960 --> 00:47:21.840
book club meetings, members would come prepared after reading a

611
00:47:21.880 --> 00:47:25.519
book of a famous woman author and that author was

612
00:47:25.639 --> 00:47:29.159
even invited from any part of the world to give

613
00:47:29.199 --> 00:47:34.000
her presentation followed by a na in this prestigious and

614
00:47:34.119 --> 00:47:35.119
elite gathering.

615
00:47:38.400 --> 00:47:41.440
And now thanks to doctor Afshan Hashmi's radio show.

616
00:47:46.760 --> 00:47:50.599
Hello everyone, this is Doctor of Sean Hashmi live from

617
00:47:50.639 --> 00:47:55.599
a barn country club in Virginia, and I just wanted

618
00:47:55.679 --> 00:47:59.039
to say that my K four SHDE radio and top

619
00:47:59.119 --> 00:48:02.760
for TV show Call Me Canry with Doctor of Shan

620
00:48:02.920 --> 00:48:07.320
Hashmi is syndicated worldwide and has more than three hundred

621
00:48:07.400 --> 00:48:11.760
million listeners. And if you want these shows to continue,

622
00:48:11.960 --> 00:48:15.239
please give a sponsorship. And I request to please give

623
00:48:15.280 --> 00:48:19.880
a sponsorship because these shows require a lot of energy

624
00:48:19.960 --> 00:48:23.400
and money to produce. So I would request every month

625
00:48:23.679 --> 00:48:29.400
to give me sponsorship and your product quild be promoted

626
00:48:29.519 --> 00:48:32.800
in a very reasonable price. And you can contact me

627
00:48:33.000 --> 00:48:40.599
at Uughshan at Drufshanhashmi dot com. Peers and bye bye.

628
00:48:41.920 --> 00:48:44.639
Would you love exposure for your business, product or service

629
00:48:44.719 --> 00:48:47.880
to over three hundred million potential listeners, Send an email

630
00:48:47.960 --> 00:48:51.440
to invo at talkform media dot com. And now let's

631
00:48:51.440 --> 00:48:58.559
hear from some of our sponsors.

632
00:49:05.559 --> 00:49:08.760
A monstrous infection is spreading worldwide.

633
00:49:09.559 --> 00:49:12.760
Oh my god. Is this a simple infection or a

634
00:49:12.920 --> 00:49:16.119
deliberate attempt to ruin the human population?

635
00:49:17.119 --> 00:49:21.960
Or maybe it's bioterrorism? What is this global infection and

636
00:49:22.159 --> 00:49:24.960
who is spreading it? Help us find out. Go to

637
00:49:25.039 --> 00:49:29.119
Amazon and search for the outbreak of a Monstrous infection.

638
00:49:29.639 --> 00:49:32.480
These human race needs your help to make this go viral.

639
00:49:32.800 --> 00:49:35.719
Go to Amazon dot com and read the Outbreak of

640
00:49:35.760 --> 00:49:37.199
a Monstrous Infection to.

641
00:49:37.159 --> 00:49:39.920
Find out what happens next. Go now.

642
00:49:40.519 --> 00:49:51.519
The world is depending on you.

643
00:49:51.519 --> 00:49:53.840
You've been listening to Meet and Great with Doctor af

644
00:49:53.920 --> 00:49:57.000
Shanhashmi on KFOHD Radio and Talk for TV.

645
00:49:57.280 --> 00:50:01.159
Tune in live right here every Thursday, six pm Eastern time.

646
00:50:01.280 --> 00:50:04.000
Would you love exposure to your business, product or service

647
00:50:04.039 --> 00:50:07.199
to over three hundred million potential listeners. Send an email

648
00:50:07.280 --> 00:50:10.719
to info at talkforremedia dot com, And remember, if you

649
00:50:10.800 --> 00:50:12.880
miss any part of the show or want to hear

650
00:50:12.920 --> 00:50:16.000
it again, find our featured show on iHeartRadio or YouTube,

651
00:50:16.039 --> 00:50:18.559
where all past episodes are available on demand.

652
00:50:18.760 --> 00:50:21.639
Twenty four to seven. See you next Thursday at six

653
00:50:21.719 --> 00:50:24.599
pm Eastern time, Right here on K four HD and

654
00:50:24.719 --> 00:50:25.519
Talk four TV.