Inspection Preparation Procedures}

Submitted by: GRC Training Solutions

Description:

This seminar is intended to discuss what FDA-regulated industry should know about FDAs inspection policy to better implement the best Good Manufacturing Practices (GMPs). The common deficiencies found based on 483s issued to medical device and pharmaceutical industries will be discussed. The most common deficiencies are based on the speakers analysis of 483s issued for the past eight (8) years.

This presentation will greatly help you better prepare for and manage an FDA inspection in a proactive and effective manner.

The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Donts before, during and after the inspection.

This presentation will provide great opportunities to become familiar with the FDA inspection policy and industrys best GMP practices including the lessons learned from the most common deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.

Areas To Be Covered in this Seminar:

Applicable Laws and Regulations

FDA Manuals and Inspection Guides

Hosting an FDA Inspection

Inspection Types and Categories

Inspection Classification

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FDA Forms 482 and 483

Common deficiencies in 483s

What/How to Prepare for and Manage an FDA Inspection

How to Communicate Before, During and After inspection: Dos and Donts

Inspection Preparation Procedures

Close Out Meeting

Responding to 483s, If Issued

How to Communicate with Emotional Intelligence

Employee Training

Actual Case Studies

Speakers PASS-IT Recommendations

Who will benefit:

CEOs

VPs

Compliance Officers

Attorneys

Regulatory Affairs

Clinical Affairs

Quality Assurance

R&D

Consultants

Contractors/Subcontractors

Anyone Interested in the FDA Drug Review and Approval Processes

Instructor Profile:

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDAs transparency public meeting in 2009.

GRC Training Solutions is a premier training and solutions company that conducts high impact training’s in Corporate Governance, Regulatory Compliance, Quality Management and Risk Management.

GRC training modules are designed and facilitated by industry experts who possess a strong theoretical and working knowledge of the required regulatory compliance requirements. GRC Training Solutions uses Government and industry best practices and relevant software tools to help companies of all sizes accelerate business performance by helping them understand how to effectively operate within the various guidelines and regulatory frameworks.The training modules are designed for senior and mid level management and executives.

GRC Training Solutions offer companies tailor made solutions that suit different professional needs and are available in different mediums live training sessions at conferences or in-house classroom training, consultation, webinars, seminars and podcasts. Whichever training module the organization opts for- classroom training or webinar each attendee will gain a thorough understanding of the key concepts of Corporate Governance. Even after professionals successfully complete the training sessions, GRC Training Solutions experts are available to answer queries and provide whatever assistance is required.

What makes GRC Training Solutions unique is a proven track record, use of latest technology, updated and engaging training modules and competitive pricing.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.Inspection Preparation Procedures

About the Author: GRC Training Solutions is a premier training and solutions company that conducts high impact training’s in Corporate Governance, Regulatory Compliance, Quality Management and Risk Management.GRC training modules are designed and facilitated by industry experts who possess a strong theoretical and working knowledge of the required regulatory compliance requirements. GRC Training Solutions uses Government and industry best practices and relevant software tools to help companies of all sizes accelerate business performance by helping them understand how to effectively operate within the various guidelines and regulatory frameworks.The training modules are designed for senior and mid level management and executives.GRC Training Solutions offer companies tailor made solutions that suit different professional needs and are available in different mediums live training sessions at conferences or in-house classroom training, consultation, webinars, seminars and podcasts. Whichever training module the organization opts for- classroom training or webinar each attendee will gain a thorough understanding of the key concepts of Corporate Governance. Even after professionals successfully complete the training sessions, GRC Training Solutions experts are available to answer queries and provide whatever assistance is required.What makes GRC Training Solutions unique is a proven track record, use of latest technology, updated and engaging training modules and competitive pricing.For More Details:Email: support@grcts.comTel: +1-248-233-2049Web:

grcts.com

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on March 20th, 2017 | File Under Medicine | No Comments -

US Senator Kennedy has brain tumor surgically removed

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US Senator Kennedy has brain tumor surgically removed

Monday, June 2, 2008

Today, United States Senator Ted Kennedy underwent surgery for a brain tumor at Duke University Medical Center. Kennedy, 76, was diagnosed with malignant glioma, a common but dangerous form of cancer, after suffering a seizure on May 17.

Kennedy has met repeatedly with friend and medical advisor Dr. Lawrence C. Horowitz to plan a course of treatment. The first, of the major phases of that treatment has now been completed, and it is expected that chemotherapy and radiotherapy will follow.

“I am pleased to report that Senator Kennedy’s surgery was successful and accomplished our goals,” said Dr. Allan Friedman, the chief of neurosurgery at Duke, who performed the surgery. “After a brief recuperation, he will begin targeted radiation at Massachusetts General Hospital and chemotherapy treatment,” Friedman added.

In talks with the press, the senator has focused on his future beyond surgery. In a prepared statement issued by his office, Kennedy stated, “after completing treatment, I look forward to returning to the United States Senate and to doing everything I can to help elect Barack Obama as our next president.”

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Metal singer Ronnie James Dio dies aged 67

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Metal singer Ronnie James Dio dies aged 67

Sunday, May 16, 2010

American metal singer Ronnie James Dio died today at the age of 67, as announced by his wife, Wendy. Dio passed at 07:45 (CST) (13:45 UTC) at the Mayo Clinic, an American disease treatment center, after a two-year fight with stomach cancer that caused him to stop singing while he received treatment. “Ronnie knew how much he was loved by all…Please know he loved you all and his music will live on forever,” added his wife in a statement on Dio’s website.

Dio (born Ronnie James Padavona) was born in July 10, 1942 in the American city of Portsmouth, New Hampshire. He was most noted for his high pitched vocals and lyrical tales involving battles and themes of good versus evil.

He performed with several hard rock and metal groups, but he was most notable for his first act, when he joined as singer of the British metal group Black Sabbath after lead singer and frontman Ozzy Osbourne left the band in 1979. Before Black Sabbath he performed with several less successful bands, including Rainbow, led by former Deep Purple‘s Ritchie Blackmore, and Elf.

He also had a very successful solo career under the simple name “Dio”, and had recently reunited with former Black Sabbath band mates under the moniker Heaven and Hell. Some of Dio’s hit songs were Holy Diver, Neon Knights, and The Last In Line.

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Mar 20

Doctors who treated John Ritter cleared of negligence lawsuit

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Doctors who treated John Ritter cleared of negligence lawsuit

Friday, March 14, 2008

Two doctors who treated actor John Ritter for chest pain in Burbank, California were cleared of a negligence lawsuit on Friday. Ritter was an American television and film actor who died of aortic dissection on 11 September 2003.

Ritter’s children and widow (Amy Yasbeck) filed a US$67 million lawsuit claiming negligence by the doctors, both at the time Ritter fell ill and at a medical checkup two years earlier where problems with Ritter’s aorta could have been spotted.

A jury hearing the case at Los Angeles County Superior Court voted 9-3 to dismiss the claims, satisfied that the defendants, Dr. Joseph Lee and Dr. Matthew Lotysch, acted properly during their examination and treatment of Ritter.

Ritter’s last role was in leading the cast of the television series 8 Simple Rules for Dating My Teenage Daughter whose production was disrupted by his death.

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Mar 19

Popular And Cute Baby Shoes}

Popular And Cute Baby Shoes

by

Jenny Riley

One of the greatest mysteries of life is the effort and money put into the purchase of baby clothing.

Infants are not bothered about the quality of their outfits. They will cry anyway, even if they are kitted in a Versace shirt!

Even this will not deter the average parent, they will still go out of their way to buy expensive baby items, chief among which are baby shoes.

Parents buy all kinds of baby shoes for their tots. From baby sneakers to little ballet shoes, name it and some babies have them.

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The strange fact is these purchases were made with the perfect knowledge that the infants are not going to run on a track or attend dancing classes.

Though, the function of baby shoes is slightly different from those of adult shoes, they still share some basic similarities.

They need to protect the fragile feet, and hold up to crawling around, and possibly a bit of drool.

And while adult shoes go through much more than this, the fact still is, almost any baby shoe will hold up just fine when the baby is not yet walking.

Thus, the other reason parents buy baby shoes is just to show off their baby’s cute shoes to friends and other people.

Things become more interesting from here.

It is generally believed that cuteness is accomplished in a baby shoe through the miniature size of its every feature.

A closer look at babies will reveal a startling fact: they are not really very attractive creatures. Not with their big heads and pudgy features.

The real thrill many get out of babies is just that they are tiny, and somewhat odd versions of us.

This is the same with baby shoes; they look like smaller, pudgier versions of our footwear.

Along with this cuteness, there are certain designs that are more popular among baby clothes, and baby shoes, than among adult clothing.

Things like butterflies, hearts, and especially little cute baby animals make a very popular design for decorations on baby shoes.

By Jenny Riley –

Baby Shoes

Article Source:

eArticlesOnline.com

}

on March 19th, 2017 | File Under Dance | No Comments -
Mar 19

2007 Taipei International Travel Fair: Taiwanese government promote premiums on tourism industry

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2007 Taipei International Travel Fair: Taiwanese government promote premiums on tourism industry

Saturday, December 15, 2007

2007 Taipei International Travel Fair (Taipei ITF), supported by governments with new premiums promoted by Executive Yuan in the future, started with a great new scale at December 14 to 17. In the opening morning yesterday, governmental people and ambassadors from several countries including Taiwan successively visited this show.

The show organizer, Taiwan Visitors Association (TVA), held 2 opening ceremonies for Cross-Strait Pavilion and the main show. In the side of Cross-Strait, several teams performed traditional entertainment shows like “Bian Lian” (Face-Changing) and Martial Arts of Shaolin Monastery (In Chinese: Shaolin Kungfu) successively at press conference and welcome reception yesterday and opening ceremony today. Participants from China and Taiwan hoped the relation from Cross-Strait can be improved with tourism industry.

In the main opening ceremony, Premier of the Republic of China Chun-hsiung Chang not only announced the premiums of “2008-2009 Visit Taiwan Year” but also said: “We (the Executive Yuan) will still encourage foreign visitors visit Taiwan and also provide premiums for groups with a charter airline. with our ‘2008-2009 Visit Taiwan Year’ in the future”.

Not only Chun-hsiung Chang, Minister of Transportation and Communications Duei Tsai, Commissioner of Tourism Bureau of MOTC Janice Lai, and the current President of Palau Thomas Esang Remengesau, Jr. visited this show. Governments in several divisions participated in this show to showcase traditional cultures from several divisions with unlimited potentials on tourism industry in Taiwan.

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Mar 18

200 candles: Chileans celebrate country’s Bicentennial

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200 candles: Chileans celebrate country’s Bicentennial

Saturday, September 18, 2010

Chile is celebrating its Bicentennial, with several events that have been organized by the government for almost a decade. It commemorates two hundred years since the First Government Junta of 1810 was formed, starting the Independence process, that ended in 1818 after Bernardo O’Higgins proclaimed it.

The Bicentennial takes place on a holiday from September 17th until 21st. Sebastián Piñera inaugurated the official fondas (places where typical food and drinks of Chile are sold; similar to a tavern) earlier on Friday. Piñera also danced a “pie” of Cueca, Chile’s national dance, with Government Spokeswoman Ena Von Baer.

More than 60 thousand people gathered on Plaza de la Ciudadanía (Citizen’s Square) in Santiago to celebrate the Bicentennial. There was a projection of historical images that also contained a message from the trapped miners in Copiapó. A giant flag of Chile (18 meters of height, 27 of width; weighing 200 kilograms) was raised on the square on Friday morning.

Celebrations of the Bicentennial in Pichilemu started earlier this month. On September 2, two thousand people lined up in a formation to create the message “Viva Chile Bicentenario Cardenal Caro” on Pichilemu beach “Las Terrazas”. The message was used to create a postal stamp to be released worldwide. The event was promoted by the Government of Cardenal Caro Province.

Private schools in the city, such as Colegio Preciosa Sangre, prepared events specially for their students. On Thursday, “Fonda Don Vicente Nario” was opened on Preciosa Sangre. Several games were performed there on that morning, including “el emboque”, “ponerle la cola al burro” (to put the tail to the donkey), and others.

Another event on Preciosa Sangre took place on Thursday night, when students recreated scenes of the History of Chile, including: a tertulia featuring Manuel Montt (starred by Luis Rojas); a chingana (a popular tavern); and selected colonial professions, such as the “motero” (person who sold motemei and chestnuts).

The official fonda of Pichilemu, La Bombonera, was inaugurated on Thursday night by Mayor Roberto Córdova, who danced cueca with people who attended the event. According to Córdova, at least 30,000 people have arrived at Pichilemu as of Friday, and it is estimated that another 30,000 will arrive during the next three days.

A great event took place on Pichilemu beach on Friday afternoon. Chilean typical games highlighted the event. People danced reggaeton, Américo’s cumbias and cuecas, while others were swimming. The National Shoe Fair (Feria Nacional del Calzado) was established on Agustín Ross Hotel on Thursday, and will stay in the town until September 23rd. Alicia Grez, who works on a kiosk in the Pichileminian Craft Fair located in front of One Discotheque, said that “sales have been excellent,” and that “[they] won’t miss the possibility to experience such an event like this.”

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File:Parque bicentenario.JPG

Postcard released by the Chilean Government in 1910. At the top, from left to right: José Miguel Carrera, José de San Martín, Bernardo O’Higgins, Lord Thomas Cochrane, and Manuel Rodríguez. At the bottom, from left to right: Manuel Vicuña, Manuel Blanco Encalada, José Manuel Balmaceda and Pedro Montt.

Official poster of the Centennial of Chile.

Official plans for the Centennial of Chile, in 1910. Pedro Montt is pictured at the top, and Bernardo O’Higgins at the bottom.Image: Memoria Chilena.

on March 18th, 2017 | File Under Uncategorized | No Comments -
Mar 18

Children of smokers more likely to go hungry, according to study

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Children of smokers more likely to go hungry, according to study

Wednesday, November 5, 2008

A medical study has identified a previously unknown risk to children of parents who smoke tobacco: hunger. Children who live in households with at least one adult smoker are more likely to be underfed, according to Dr. Cynthia Cutler-Triggs of the New York University School of Medicine and Bellevue Hospital.

Dr. Cutler-Triggs’s study measured food insecurity, a concept used by the U.S. Department of Agriculture since the 1990s to measure the frequency of skipped meals and how often people go to bed hungry. Researchers examined data on 8,817 households from the U.S. Centers for Disease Control and Prevention‘s National Health and Nutrition Examination Survey. The study parsed the survey, which tracked the health and nutritional status of adults and children in the United States, according to smoking habits and household income.

17 percent of children in low income smoking households suffered food insecurity, compared to an overall food insecurity rate of 11 percent among children. Severe food insecurity occurred among 3.2 percent of children in smoking households.

Only 0.9 of children from nonsmoking households had severe food insecurity. Similar rises in food insecurity occurred among adults from smoking households, but researchers were more concerned about the effects on the health of growing children.

We know that there are long-term consequences of food insecurity for children.

Dr. Michael Weitzman, chairman of pediatrics at New York University School of Medicine, told The Washington Post, “We know that there are long-term consequences of food insecurity for children. They are more likely to do poorly in school, to have iron deficiency and anemia, and to have behavioral and social problems.”

An estimated 2 percent to 20 percent of smokers’ incomes goes for tobacco, which may compete with the grocery budget in some families. Household income accounted for some but not all of the difference in food security. Dr. Weitzman expressed concern that a continued recession may worsen the problem. “If the economic downturn persists, both food insecurity and adults smoking are likely to increase… [because smoking] is one of the hardest addictions to give up.”

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Mar 18

Rat Removal Company Are They Still Relevant Nowadays?}

Submitted by: Cory Frank

Usually, most of us commit the error of underestimating rats. A few of us have the belief that rats can be annihilated just by applying rat poisons for rat or by planting traps around the house. This may likely be valid if there are just a couple of rats in your home. In any case, if the rat infestation is well advanced, then you will obviously be squandering your time as it were.

With the blast of numerous reading materials and information on the most proficient method to destroy rats and diverse pests, the question is, so what is the need for rat and pest removal company? It appears that with the invention of the internet, leading to circulation of a lot of information on how to do this or that, pest organizations have gotten to be unsettled and scholarly. What is the basis for us to depend on them again when we can effortlessly read up what they can do and then complete the task all by ourselves?

If I would be absolutely true to you, organizations that offer services like rat removal in Jersey City, NJ, roaches removal in Brooklyn NY, termites control in Jersey City, NJ, bed bugs control in Jersey City, NJ or pest control in Brooklyn, NY are still very much needed today and even in the future. Obviously, it is to your benefit if you know fairly well about prevention of rat, yet when it truly comes to confronting extreme infestation, then there’s not a viable replacement for experience. Yes, information may be here and there, yet it doesn’t make us an authority. Why? It takes more than head knowledge; it takes productive years of experience to accumulate expertise.

There is a gap between theory and practice. Both may not be consistent with each other. There are meanings which are hidden between lines of information you read which can only be revealed by experience. Rat removal, for one, is not as straightforward as it appears. It includes a great deal of understanding and acquaintance on the most proficient method to approach and deal appropriately with infestation issues. Skills and experience cannot be increased or attained in an hour, a day or even within a month. These special qualifications and needs are very pivotal to effectively get rid of obstinate and stubborn rats once and for all.

As rightly seen, you are not unlikely to be able to remove rats, termites and even cockroaches all alone. You can just hope that you truly nailed it. Nonetheless, don’t be frustrated if after only a couple days the pests are fully back in your wardrobe. Avoid committing the error that since you could deal with a couple fledging nests of rats, you are now a specialist who could really handle rat infestation.

It’s exceptionally frustrating to have the rats return again over and over. That is the thing that normally happens when you do the rat extermination yourself. In any case, with a professional ram removal organization taking over the responsibility of the situation, you are certain that the infestation will be totally annihilated when they are done.

About the Author: For more information, click the following links; pest control Brooklyn, NY, bed bugs control Jersey City, NJ and termites control Jersey City, NJ, or visit this website,

bugbossllc.com/

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on March 18th, 2017 | File Under Tree Removal | No Comments -
Mar 18

Steve Jobs denies ‘location-gate’

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Steve Jobs denies ‘location-gate’

Friday, April 29, 2011

Apple Inc. CEO Steve Jobs announced on Wednesday that iPhone technology is not being used to monitor the location of its customers. The scandal arose from concern that data collected by Apple would make it possible for anyone with access to a person’s private computer to retrieve information about their movements.

Jobs acknowledged that while iPhones keep a database of Wi-Fi and cell tower hotspots these do not reveal anything about individual users’ location. “That’s what people saw on the phone and mistook it for location”

In a separate statement, Apple clarified the device is merely caching data in order to improve the speed of locating users in the future.

Jobs confirmed during the interview that Apple would testify before the United States Congress. “They have asked us to come and we will honour their request, of course.”

Apple have since made plans to release software updates that will cut the size of the wireless hotspot location database stored on its iPhones.

The data scandal, coined ‘Location-gate’ has overshadowed news of Apple’s announcement for sales of the delayed white iPhone 4 which will begin shipping from Thursday.

on March 18th, 2017 | File Under Uncategorized | No Comments -