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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
Some warning letters from FDA will be discussed as case studies
Meet and Greet with Dr. Afshan Hashmi
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...

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.

0:01 This program is designed to provide general information with regards to the subject matters covered. This information is given with the understanding that neither the hosts, guests, sponsors or station are engaged in rendering any specific and personal medical, financial, legal, counseling, professional service, or any advice. You should seek the services. Of confident professionals before applying or trying any suggested ideas. Books, PD, products, science, fashion and glam talk from Bollywood to Hollywood. It's Meet and Greet with Doctor Ashan Hashmi right here on kate FURHD Radio and Talk for TV.

0:44 And here's your host, international speaker, educator, award winning entrepreneur and best selling author, Doctor Ashan Hashmi. Hello everyone, this is your loving post Doctor of Shan Hashmi live from a studio in Rockville, Maryland, and today I am here at Hollywood Radio a live meet and read with Doctor of Shan Hashmi. And this show will be syndicated worldwide two three hundred million listeners. So, folks, if you want to give me sponsorship, please give me sponsorship because in a very reasonable price, I will give you a sponsorship and you can contact me at Ashan at arrafshanhash MEI dot com. Having said that, folks, I just want to remind you that these are my two books.

1:38 The first one is the Modern moven Mentality, New Strategies to succeed in India and the global marketplace. When this book came, there was a lot of result going on on Juguard and I have conceptualized Juguarde as thinking outside the box. The second one is The Outbreak of a Monstrous Infection. And when this book came, there was no COVID and in a very creative way, I have devised a story which shows that how bioterrorism can run the human population as COVID has done. And the best part is that COVID had not been introduced in the world when this book came. Having said and this book was Amazon bestseller, and this one was also Amazon bestseller, Modern mole Mentality with the hot number one new release on Amazon.

2:36 And now, folks, I will I want a documentary to be made of this book, So all those documentary producers please contact me at Afshan at drrafshanhashme dot com. And for this Outbreak of a Monstrous Infection, I want a movie to be made. And tail Flix has given a very good evaluation of this, So please call go at my website Afshan www dot Shanhashmi dot com and see what you can get out of it. And having said that, folks, now you know I want now I want to like sponsorship for my show and I will ask my sound engineer Rebel to please play the sponsorship first film.

3:30 Hello, viewers around the group. This is doctor Shan Hartman, a live. For her radio show at pay four SHB and talk for TV show and I just wanted to. Request you that wase give me a sponsorship if you want to. Want this show to continue. Having set that fence, I will see you in another. Episode of K four Strato. Plus for TV show And if you give. Me a sponsorship, I will give you very reasonable price and the also you will get a lot of promotion as this show is significated L right to move them thro will those cheers.

4:14 And bu B. So, folks, now you know today's topic is like I will discuss a case study with a warning letter from FDA. I'm a regulatory affairs a specialist also, and I have a consulting company, Doctor Rashan Hashmi Consulting Growth. So if you have any of those needs, please contact me at Aughshan at drrafshanhame dot com and folks so from FTA page I got this and here it is development and approval process of drugs. Developing new drugs, American consumers benefit from having access to the saface and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA Center for Drug Evaluation and Research CDER.

5:07 The center's best known job is to evaluate new drugs before they can be sold. CEDARS evaluation not only prevents poetry, but also provide doctors and patients the information they need to use medicines wisely. The center ensures that drug, both brand name and generic, work correctly and then help benefits outweigh their known drinks. Drug companies seeking to sell a drug in the United States but first tested the company then sets CEDAR the evidence from these tests to prove that drug is safe and effective for its intended use. A team of SEDAR physicians, statisaians, chemist pharmacologists, and other scientists reviews the company's data and propose labeling. If this independent and unvised review established that a drugs help benefits outweigh its known risks, the drug is approved for sale.

5:58 The center doesn't actually does drugs itself, although it does contact limited research in the areas of drug quality, safety, and effectiveness standards. So, uh, folks, you know, the drug approval process is a very long process, and it was billions of dollars for a drug to come in the market. And the first of all, you know, like if if FDS says that this drug is not good for approval or if it is approved, they have to go and see the manufacturing facility. So I won't take the name of the company. There was a company announcement and it's say and usually companies, when when they see a problem, they voluntarily recall this drug. So is voluntary recalling the eye Drops product listed in the table below to the consume consumer level, with all lots within expiring with expiration dates ranging from November twenty twenty three to September twenty twenty five for all the below mentioned products. So there was this drug and you know they voluntarily recall it.

7:11 Voluntarily recall means that you know, they thought that the drug is not up to the mark and they recalled it. So but you know, in India, and this drug was from India, a clinical trial outsourcing is a big game in India and big pharmaceutical companies from here are sourcing their clinical trials in India. And I have a big problem with that. You know, I have myself in my consulting company. I have gone to these CROs they are called clinical research outsourcing companies and they don't show their patient pool. They don't show their patient pool. And if they don't show their patient pool, it's very risky to see if a diabetes clinical I have seen a diabetes clinical trial like one person. You know, at the same time they're they're getting diabetes clinical trials, they are getting lots of other cancer clinical trials. The vass are used.

8:16 So this is a big game in India. And the company I was auditing, I asked them that they never showed me the clinical trials outsourcing thing, that what is their patient pool? And there are a lot of manufacturing facilities in India. Let me go on a break and then I will come and talk about it. Would you love exposure for your business, product or service to over three hundred million potential listeners? Send an email to infoids talkform media dot com and now let's hear from some of our sponsors.

9:03 Chapter two how Jugar leads to multi sector sex stories in India, including definitions of the Jugar management, principal business model of the book, the modern Mobile mentality, news strategies to succeed in India and the global marketplace. Inspiration through Jugar is an inspiration on how to create products using technology that meet the price value equation. According to a Harvard Business Review article featuring expert prellad Than Marshalker, most innovation programs are built on the assumptions of affluence and abundance.

9:43 We see the rich and the young in both the developed and the developing countries demanding environmental friendly products and services. They also believe that affordability and sustainability are crucial to driving successful business to New technologies and radical business models are important not only to benefit mass markets in India, but in the entire world. By Configura during all areas of the business fructilled Davenport.

10:28 Hey, monstrous infection is spreading worldwide. OMG. Is this a simple infection or a deliberate attempt to ruin the human population? Or maybe it's bioterrorism. What is this. Global infection and who is spreading it? Help us find out? Go to Amazon and search for the outbreak of a monstrous infection. The human race nature helped to make this go viral. Go to Amazon dot com and read the outbreak of a monstrous infection to find out what happened next. So now the world is depending on you.

11:16 And now doctor ours on hashme's radio shows. So first Now. Clinical trial outsourcing in India has been a growing trend in recent years, driven by several factors, cost reduction, access to experience professionals, research and development promotion. Contract Research organization CROs are mushrooming across India, competing with each other to provide clinical trial services for pharmaceutical companies. US companies have been have even acquired Indian CROs to use as ups for their clinical research activity. How are The outsourcing of clinical trials to India has also been the subject of some controversy. Some have raised concerns that the outsourcing may not be relevant to the country's public health needs, and there have also been allegations of unethical conduct.

12:17 Clinical trials in India continue to be in the news, unfortunately a fair bid being negative coverage. Over the last few years that has been continuing outrage on the issue of rising outsourcing clinical trials to India with concerns about little benefit or relevance to the public health needs of the country. And I was talking about this earlier. And the Drug Controller Journal of India grant's approval for clinical trials and is the top level authority when it specifically overseas clinical trials. The Drug Controller is a part of the Central Drug Standard Control Organization and answers to that western And I have seen that office and I'm sorry to say that it's not up to up to the mark.

13:07 And even you see on the rooftop of that there are a lot of baboons and there are a lot of monkeys there and I don't know what like it is so dangerous, you know to go there. When I went there, I saw that. Now I don't know what the situation is. Okay, Submission of Ethics approval and DCGI approval, if applicable, is essanchell for trial registration in the CTRII. So multi country trials where India is a participating country which have been registered in an international registry are also expected to be registered in the CTRII Clinical Trials Registry India.

13:52 And now I will go on a break and We'll be back soon. Would you love eposure for your business, product or service to over three hundred million potential listeners, send an email to info at talkformedia dot com. And now let's hear from some of our sponsors. A monstrous infection is spreading worldwide. Oh my god. Is this a simple infection or a deliberate attempt to ruin the human population? Or maybe it's bioterrorism. What is this global infection and who is spreading it? Help us find out. Go to Amazon and search for the Outbreak of a Monstrous Infection. These human race needs your help to make this go viral. Go to Amazon dot com and read the Outbreak of a Monstrous Infection to find out what happens next.

14:56 Go now, the world is depending on you. The Outbreak of a Monstrous Infection Chapter one, nineteen sixty four to twenty eighteen. And this is the sample track and it is read by doctor Rafshan Nahid Hashmi in a sprawling banglaw. In Potomac, Maryland, USA, lived doctor Honey Singh, a both certified internal medicine and family practice physician, along with his beautiful wife, Baby Singh. Baby Singh was a fashionista and was funding women's causes through her Honeybay Foundation.

15:44 She had a lady's book club by the name of Baby's Clam and Glitzy Club, which had many clam and Glitzy ladies who were professionals living in Washington, DC, Potomac, Maryland, Virginia, and even Beverly Hills, California, as well as a lead from all of America, meeting at her place on the last Wednesday of every month discussing various aspects of charities they wanted her and doctor Honey to fund. In this club, there was a wide spectrum of career women. There were doctors, lawyers, actresses, business owners, and models to name a few. In these book club meetings, members would come prepared after reading a book of a famous woman author and that author was even invited from any part of the world to give her presentation, followed by a q anda in this prestigious and elite gathering.

16:43 And now thanks to doctor Ashan Hashmi's radio shows. The Indian pharmaceutical industries projected to grow at a cger of over ten percent to reach a size of US dollars one thirty billion by twenty thirty. India has emerged as the medical tourism hub of the world, providing cost effective treatments with the latest technology, enabled by several power breaking reforms and provisions. Access to affordable CHIV treatment from India is one of the greatest success stories in medicine. India is one of the biggest suppliers of low cost vaccines in the world. Because of the low price and high quality, Indian medicines are preferred worldwide, thereby rightly making the country the pharmacy of the world. India has been traditionally quite strong in the pharma sector, with a low cost of manufacturing thirty percent to thirty five percent lower than the US and Europe, cost efficient R and D about eighty seven percent less than the develop market and keep skill labor. On December twenty one, twenty two, MoU was signed between Tata Memorial Center of India and Wetness Armed National Cancer Center to a cancer hospital to promote exchanges in the areas of training and scientific healthcare services, collaboration in diagnosis and treatment for cancer patients, the treatment for cancer patients. The total market size of the Indian

18:16 farmer industry is expected to reach US dollars one thirty billion by twenty thirty and US dollar four fifty billion market by twenty forty seven. The domestic pharmaceutical industry would likely reach US dollar fifty seven billion by f y twenty five and see an increase in operating margins of one hundred to one fifty basis point pps. India has the largest number of USFDA compliant pharmaceutical plants outside the US and over two thousand who GMP approved festival Tea serving demand from one fifty plus countries worldwide, with ten thousand, five hundred plus manufacturing facility. So the warning letter I have taken around disclose the company is of the warning letter they got from Issuing Office Center for Drug Evaluation and Research SED the United States, and it says the US Food and Drug Administration since there are so many manufacturing facilities and people outsource that for cost efficiency. But I am not very very happy with the what I read here and the cost is uh uh. I know cost is lower than US, but there you know, the manufacturing facilities are not up to the mark. I have seen clinical trial outsourcing. I haven't seen the manufacturing facility in India. But you know, this is a very depressing, depressing thing about India. So companies who are outsourcing in

19:51 UH the India UH should should pay attention that if if a drug is approved in America, then it should it should have been very very efficient process and very very like clean process, you know, and cGMP. Sure, and I have worked on cGMP and like in a manufacturing facility and in quality control. So it has to be up to the mark. And see it says the US Food and Drug Administration FDA inspected your drug manufacturing facility.

20:35 This forming letters summarizes significant violations of current Code Manufacturing Practice c GMP regulations for Finnish mceuticals see Title twenty one Code of Federal Regulations CFR Part two twenty and two eleven twenty one CFR Part two ten and two eleven. And now of your friends, let me go. Because your method, facility, or controls for manufacturing, processing, packing, or holding do not conform to c GMP. Your drug products are adulterated within the meaning of section five oh one A two B of the Federal Food, Drug and Cosmetic app FDNCF T L fewer USC three five one A two B because your drug products were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered Injuryers to help your drug products are also deliberated within the meaning of section FIVEH one A two A of the fdn C At twenty one USC three five one A two A, we review t or November ten, twenty three response to our form FDA four eighty three in detail and acknowledge received of your subsequent correspondence so

22:11 FDA four eighty three is the warning letter which is issued by FDA. During our inspection, our investigators absorbed specific violations, including, but not limited to, the following conditions and in sanitary conditions. Your drug products are adulterated under section five oh one A two A of the FBCC because they were prepared, packed, or held under insanitary conditions. FDA investigators observed your facility to be in a state of despair, poorly cleaned and maintained it as evidenced by B four residue on the B four adjacent to the HIPPA filters in the ISO five area. Multiple barefoot employees in ISO it area without required gowning, including gloves, while handling materials being transferred into the ISO seven manufacturing area operators use visibly dirty restricted access barrier system wraps before for interventions on the filling line, your response is not adequate. While you commit to replacing the bfore that surround the HIPPA filtration system, your response does not include an evaluation of the resudue on the B four to determine its identity or investigate the source.

23:37 You also commit to perform retraining personal for gowning requirements and implement procedure for stralization of wraps before. However, you do not evaluate the micro microbiological impact that lack of proper gowning and in uncleaned wraps before has on your classified area such as ISO five, ISO seven, and ISO eight. The potential impact to spalde drug products produced under these insanitary conditions is also not addressed. So now I will go on a break and we'll be back soon.

24:17 Would you love exposure for your business, product or service to over three hundred million potential listeners? Send an email to infots talkform media dot com and now let's hear from some of our sponsors. Chapter two, How jugar leads to multisector seccess stories in India, including definitions of the JUGAR management, principal business model of the book The Modern Mobile Mentality, News strategies to succeed in India and the global marketplace, inspiration through jugar is, and inspiration on how to create products using technology that meet the price value equation. According to a Harvard Business Review article featuring expert prellad Than Marshalcare, most innovation programs are built on the assumptions of affluence and abundance. We see the rich and the young in both the developed and the developing countries demanding environmental friendly products and services.

25:27 They also believe that affordability and sustainability are crucial to driving successful business today. New technologies and radical business models are important not only to penefit mass markets in India but in the entire world. By reconfigure during all areas of the business structure, they will. Hold Hey, monstrous infection is spreading worldwide. OMG.

26:08 Is this a simple infection or a deliberate attempt to ruin the human population, or maybe it's bio terrorism. What is this global infection and who is spreading it? Help us find out? Go to Amazon and search for the outbreak of a monstrous infection. The human race. Nature helped to make this go viral, go to Amazon dot com and read the Outbreak of a Monstrous Infection to find out what happens next. Go now the world is depending on you.

26:51 And now back to Doctor Offshan Hashmis radio show. So Firth, Now, I want to say that you know it should be America first. You know, it should not be like I know, the manufacturing facilities are less expensive in India, but look at look at this warning letter example, how how poor quality it's an opthalmic product. Uh product you put it in your eye and the way it has been done, you know, and there are many many problems you know in manufacturing facilities in India and here.

27:37 If we make drugs or products here, drug products or medical devices products here, you know, there will be so much jobs for America. And I see I am without without a job. You know, I do this show. If I get a sponsorship, you know I will get a sponsorship. It is very hard, you know, to sustain these kinds of shows without a sponsorship. So this show will be syndicated worldwide two three hundred million listeners. So please give me a sponsorship, and now let me see and see the quality of the work. It says c GMP violation. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drugs products computing to be sterile, and that include validation of all acceptic and asterilization processes. Poor practices in the accepting processing areas.

28:38 In addition to the insanitary conditions described above, during the inspection of your facility, we observe poor practices and behaviors in ISO five areas during the manufacturing of a sterile drug products. These poor practices included, but are not limited to, operators performing interventions on the filling line in ISO five areas using a plot to wipe the B four of the filling B four and the conveyer operators leaning over the filling line, including open and filled eye drop bottles blocking unidirectional airflow, operators in the ISO five area not wearing goggles and therefore had exposed a skin during line set up, and ACCEPTIC processing operators observe placing bags of component that made contact with the walls in the ISO seven area into the ISO five area without the bags being disinfected. So if FDA is manufacturing, If FDA is doing inspection. So that means you know, the manufacturer had plans to bring the drug to US market or they want to make there are two things. They want to make FDA compliant facility so that they can get more projects from US and other countries which which believe that FDA has the highest level you know of uh like

30:09 the highest level of regulations, so they can make FDA compliant facility to advertise it that they have FDA compliant facility. Now this is an FDA compliant facility. But see how much problems they have. So so I think you know it. The best is to have manufacturing facilities in America where people can you know, have jobs. Having set that forth, now I will go on a break and will be back soon. Earlier around the right and top for in friends, I am never in a country.

31:00 And just. Go on money to produce these. Having sept the. Partnership, actual and say inadequate smoke studies. Smoke studies performed by your firm are not adequate to show unidirectional airflow in the acceptic processing areas. Multiple instances of turbulent airflow in critical areas of the B four filling line were noted, including above the filling before. In addition, smoke study videos did not include setup of the aceptic processing line or interventions of the filling line that stimulate actual manufacturing. There is so much a problem in this manufacturing site. Your firm failed to ensure the laboratory records, including complete data derived all test necessary to ensure compliance which established specifications and Standard twenty one CFI two eleven point one ninety four A. Your firm failed to collect the required amount of environmental and personal monitoring samples required by your procedures to support the manufacture of a sterile products during the inspection.

32:27 A reconcili consaliation of samples that should have been taken during manufacturing activities and those that were actually taken did not match. Interviews with microbiology laboratory staff and management confirmed that it is your routine practice to fabricate results for samples that were never taken or to alter results for samples that would otherwise fail to meet establish a specification that record information for environmental monitoring is not recorded at the time of completion. For example, a badge record was being filled out in the microbiology laboratory on October twelve, twenty twenty three, for bat B four that was manufactured in March twenty twenty three, approximately six months prior to the recorded date. Data of the microbil activity in the filtration slack filling area in the batche record was blank on October twelve, twenty twenty three. This includes the air sample and non viable particulate counting, start and end time activity done by signatures and dates and checked by signatures on date when the record was later provided on October nineteen, twenty twenty three, the record was filled out with time, signatures and dates in March twenty twenty three. Laboratory technicians, now this is very important. Laboratory techians falsified this data which is critical to maintaining in ongoing day of control

34:00 in your septic processing facilities. So data was made up. How cruel this is. So, I think my recommendation would be that even if the cost is high, the manufacturing facility should be in America and it should not be outsourced to India to these kind of manufacturing facilities. Having said that, folks, now I will go on a break and will be back soon. Would you love exposure for your business, product or service to over three hundred million potential listeners send an email to infots talkform media dot com and now let's hear from some of our sponsors.

34:54 Chapter two, How Jugar leads to multisector success stories in India, including definitions of the Jugar management, principal business model of the book, the modern Mobile mentality, news strategies to succeed in India and the global marketplace. Inspiration through Jugar is an inspiration on how to create products using technology that meet the price value equation. According to a Harvard Business Review article featuring expert prellad Than marshalcre most innovation programs are built on the assumptions of affluence and abundance. We see the rich and the young in both the developed and the developing countries demanding environmental friendly products and services.

35:43 They also believe that affordability and sustainability are crucial to driving successful business Today. New technologies and radical business models are important not only to benefit mass markets in India, but in the entire way by re consi during all areas of the business structure they're in. For Hey, monstrous infection is spreading worldwide? OMG. Is this a simple infection or a deliberate attempt to ruin the human population, or maybe it's bioterrorism.

36:32 What is this. Global infection and who is spreading it? Help us find out. Go to Amazon and search for the outbreak of a monstrous infection. The human race nature helped to make this go viral. Go to Amazon dot com and read the outbreak of a monstrous infection to find out what happens next. Go now the world is depending on you. And now doctor Ops on Hashmes radio show.

37:17 So now this is data integrity remediation. Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effects, fiveness, and quality of the drugs you manufacture. C FDS Guidance Document Data Integrity and Compliance with Drugs cGMP for guidance on establishing and following cGMP compliant data integrity practices at STT based slash flash www dot FDA dot gov slash Media one one, nine, two, six, seventh SLADE download. We acknowledge that you are using an independent then third party consultant to audit your operation and assist in meeting a FDA requirement. In response to this letter, provide a comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include a detailed investigation protocol and methodology, summary of all laboratories, manufacturing operations and systems to be covered by the assessment, and a justification for any part of your operation that you propose to exclude. Interviews of current and former employees to identify the nature, scope and root cause of data. Now, every data in accuracies here, I will say that every

38:48 term tick and carry wants to make quick money. And this is a very very serious thing that they are making data, you know, And I'm so disturbed to see this and what kind of consultant was auditing this that they did not help them in that. So the best thing is not to outsources to these kind of manufacturing facilities which say they are FDA compliant but are not doing a good job. So the best way is to have a manufacturing facility in US, FDA compliant manufacturing facility in US and produce your drugs here in US only.

39:30 That is the best thing because in clinical trial outsourcing, I had a very bad experience. I saw that you know, the company, the CROs, you know, they don't show their patient pool. And I have even put this up at Regulatory Affairs Professional Society a meeting, and I asked that questions to Big pharmas over here their executives were in the panel. They did not answer to me directly, and that means there is a problem. Having said that, we recommend that these interviews be conducted by a qualified third party. An assessment of the extent of data integrity definition deficiencies at your facility. Identify omissions, alterations, deletions, record restruction, non contempoerinious record completion and other deficiencies. Describe all parts of your facilities operations in which you discover data integrity lapses.

40:32 A comprehensive retrospective evaluation of the nature of the testing data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches where identified, should evaluate all data integrity lapses. A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analysis of the risk to patients caused by the release of drugs affected by a lapse of data integrity, and analysis of the risk posed by ongoing operations. A management strategy for your firm that includes the details of your global cape A plan. Your study should include at a detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all data you generate, including analytical data, manufacturing records, and all data submitted to FDA. A comprehensive descruption of the root causes of your data integrity lapses, including evidence that the scope and depth of the current plan should is commensurate with the findings of the investigation and risk assessment. Indicate whether individual is responsible for data integrity lapses remain able to influence SEGEMP related or drug application data at your form and the regulatory affairs professional

42:06 there is responsible in the company is responsible to see that, or if they hired somebody else as a consultant, that person is responsible. But ultimately the thing comes on the CEO of the company. So the CEOs of the company should be very very very They should see who their regulatory affairs specialist is and what his or her qualification is so that these kinds of things are not happening, and whether their expertise in manufacturing in inspection of manufacturing facilities. Having said that, folks, you know now the time is getting uh. So these are my two books. The first one is The Outbreak of a Monster's Infection and the sec and the and this book. The second one is The Modern Mobal Mentality news strategies to succeed in India and the global marketplace. So when this book came, the Modern Local Mentality was my first book, there was a lot of research going on. Juguar and I have conceptualized ju guard as thinking outside the box and the and I want a documentary to be made and many American and global companies are in this. So please go and buy this book. And please all those documentary producers please contact me at a Shan at trshan archme dot com.

43:36 This will be a very good project for a documentary film. The second one the Outbreak of a Monstrous Infection. I want a movie to be made or a web series or a TV serial and tail Flix has given me a very very good evaluation of this and this was Outbreak of a Monster's Infection was Amazon bestseller as well as this one. Modern Moble Mentality was Amazon bestseller and hot number one new release on Amazon. Having set that, folks, now I will say cheers and bye bye, and the remaining of the time, Rebel my sound engineer will play another commercial. And this show is syndicated worldwide to three hundred million listeners. So if you give me sponsorship, it would be great, because to sustain these kind of shows, it's very difficult. It make a You have to spend a lot of money to sustain these kind of shows.

44:38 And I want a sponsorship to make money for me because these books, you know, these two books, and sponsorships bring food to that table. Having set that folks, cheers and bye bye. Would you love exposure for your business, product or service to over three hundred million potential listeners. Send an email to info at talkformedia dot com and now let's hear from some of our sponsors. A monstrous infection is spreading worldwide.

45:22 Oh my god. Is this a simple infection or a deliberate attempt to ruin. The human population, or maybe it's bioterrorism. What is this global infection and who is spreading it? Help us find out. Go to Amazon and search for the outbreak of a monstrous infection. These human race needs your help to make this go viral. Go to Amazon dot com and read the Outbreak of a Monstrous Infection. To find out what happens next. Go now, the world is depending on you.

46:06 The Outbreak of a Monstrous Infection Chapter one, nineteen sixty four to twenty eighteen. And this is the sample track and it is read by doctor Rafshan Nahi Hashmi in a sprawling banglaw. In Potomac, Maryland, USA, lived doctor Honey Singh, a both certified internal medicine and family practice physician, along with his beautiful wife, Baby Singh. Baby Singh was a fashionista and was funding women's causes through her Honeybay Foundation. She had a lady's book club by the name of Baby's Clam and Glitzy Club, which had many clam and Glitzy ladies who were professionals living in Washington, DC, Potomac, Maryland, Virginia, and even Beverly Hills, California, as well as a lead from all of America, meeting at her place on the last Wensday of every month discussing various aspects of charities they wanted her and doctor Honey to fund. In this club, there was a wide spectrum of career women. There were doctors, lawyers, actresses, business owners, and models. To name a few. In these book club meetings, members would come prepared after reading a book of a famous woman author and that author was even invited from any part of the world to give her presentation followed by a na in this prestigious and elite gathering.

47:38 And now thanks to doctor Afshan Hashmi's radio show. Hello everyone, this is Doctor of Sean Hashmi live from a barn country club in Virginia, and I just wanted to say that my K four SHDE radio and top for TV show Call Me Canry with Doctor of Shan Hashmi is syndicated worldwide and has more than three hundred million listeners. And if you want these shows to continue, please give a sponsorship. And I request to please give a sponsorship because these shows require a lot of energy and money to produce. So I would request every month to give me sponsorship and your product quild be promoted in a very reasonable price. And you can contact me at Uughshan at Drufshanhashmi dot com. Peers and bye bye.

48:41 Would you love exposure for your business, product or service to over three hundred million potential listeners, Send an email to invo at talkform media dot com. And now let's hear from some of our sponsors. A monstrous infection is spreading worldwide. Oh my god. Is this a simple infection or a deliberate attempt to ruin the human population? Or maybe it's bioterrorism? What is this global infection and who is spreading it? Help us find out. Go to Amazon and search for the outbreak of a Monstrous infection.

49:29 These human race needs your help to make this go viral. Go to Amazon dot com and read the Outbreak of a Monstrous Infection to. Find out what happens next. Go now. The world is depending on you. You've been listening to Meet and Great with Doctor af Shanhashmi on KFOHD Radio and Talk for TV. Tune in live right here every Thursday, six pm Eastern time. Would you love exposure to your business, product or service to over three hundred million potential listeners. Send an email to info at talkforremedia dot com, And remember, if you miss any part of the show or want to hear it again, find our featured show on iHeartRadio or YouTube, where all past episodes are available on demand.

50:18 Twenty four to seven. See you next Thursday at six pm Eastern time, Right here on K four HD and Talk four TV.