logo
logo
AI Products 
Pricing
Community
menu-h
  1. Leisure, Travel and Tourism/
  2. Hotels

Israel Joffe

avatar
israeljoffefda
Israel Joffe

I am  Israel Joffe FDA For nearly 20 years, I have been developing my skills and experiences at major organizations such as Starwood Hotels, Fox 5 News, ABC News, Fox News and the Food and Drug Administration. In that time, I have worked in various roles that have given me a vast array of experiences in project management, IT development, infrastructure procurement, requirements gathering, writing and editing news, videos, websites, developing social media strategies and more.


collect
0
avatar
israeljoffefda
Related Articles
Israel Joffe
Israel Joffe 2021-05-31
img

Israel Joffe works at the FDA in DC, the Food and Drug Administration.

He also trained for many years with WWE Hall of Famer Johnny Rodz and still occasionally helps with his digital content.

collect
0
Unlocking FDA Compliance: The Role of FDA Lawyers, Labels, and Attorneys
Marketing Outreach 2024-04-24
img
Navigating the complex landscape of FDA regulations requires expert knowledge, and FDA lawyers, FDA labels, and FDA attorney are indispensable in this process. The Role of FDA LawyersFDA lawyers are legal professionals specializing in FDA regulations and compliance. Labeling Compliance: FDA regulations mandate that product labels provide accurate and truthful information to consumers. While similar to FDA lawyers, FDA attorneys may have broader legal expertise beyond FDA regulations, including administrative law, litigation, and corporate governance. Key responsibilities of FDA attorneys include:Legal Representation: FDA attorneys represent clients in administrative proceedings, negotiations with the FDA, and litigation involving FDA regulations.
collect
0
Compliance to FDA 21 CFR Part 11 Requirements
jack 2021-05-11
img

This whitepaper documents ComplianceQuest’s position regarding compliance to Electronic Records; Electronic Signatures 21 CFR Part 11.

Some industrial segments need to be exponentially stringent with their quality and compliance processes compared to other segments.

The Life Science industry is part of this stringent segment.

They need to ensure the quality of their products because they deal with human safety.

The accuracy and efficiency of their work could well be a matter of life and death.

collect
0
Why Do You Need Foreign Business License in Thailand: Beginner’s Guide
Interloop 2022-06-01
img
Under this law, Foreign Business License is given to non-Thai nationals who want to have the majority share in an organization established in Thailand. However, starting a legally approved business also means that foreigners will need a Foreign Business License and FDA registration to aware cabinet officers of the manufacturer and the devices. The Foreign Business License (FBL) benefits international entrepreneurs and investors by getting 100% ownership of their business share in Thailand. The Foreign Business License requires minimum Capital of three million Baht for each business. Therefore, Foreign Business License bridges that gap for foreigners who want to grow their business in Thailand.
collect
0
Information about FDA 510k Approval for US
Jassy Sam 2022-09-23
img
What Does a FDA 510( k) Clearance mean? When a medical device is cleared, this means it has experienced a 510( k) submission, which FDA has reviewed and handed clearance. For Class III medical devices to be legally marketed they must suffer a rigorous review and approval process orpre-market approval( PMA). Our team of good experts will successfully prepare and submit FDA medical device regulatory documents for theU. Technically, under the 510( k) process, the FDA doesn't “ authorize ” medical devices and IVDs; the FDA issues a “ clearance ” or “ Approval ” for deal in the United States.
collect
0
California Department of Public Health: Ensuring Safety with Export Certificates
mybestfd 2024-05-11
img
In the dynamic world of consumer products, safety is paramount. The California Department of Public Health (CDPH) plays a crucial role in safeguarding consumers by regulating over-the-counter (OTC) products through FDA regulatory standards. For manufacturers, obtaining export certificates from the CA Department of Public Health is essential for seamless international trade. ConclusionIn an ever-evolving landscape of consumer products, the California Department of Public Health remains steadfast in its mission to protect the public. Through export certificates, stringent regulations, and collaboration with regulatory bodies like the FDA, the CDPH ensures that consumer safety is never compromised.
collect
0
WHO TO FOLLOW
MORE FROM AUTHOR
Israel Joffe
israeljoffefda 2022-02-01
img
collect
0
guide
Zupyak is the world’s largest content marketing community, with over 400 000 members and 3 million articles. Explore and get your content discovered.
Read more
WHO TO FOLLOW
Press enter to search  enter
articles
The FDA 510k Submission Process: What You Need to Know
Maven 2023-02-24
img
 Stages of FDA 510k process 1. The FDA 510k submission process can be complex and time consuming, so it is important to work with an experienced regulatory consultant to ensure that the submission is complete and accurate. The first step in the FDA 510k submission process is to create a device description. The FDA 510k submission process is an important step for any medical device manufacturer who wishes to sell their device in the United States. One-stop Solution for US FDA 510kMaven is one of the best regulatory consultants for the US FDA 510k services of your product.
collect
0
10 Effective Strategies to Mitigate Risk and Minimize FDA Detention Issues
myfdalaw 2024-05-30
img
However, non-compliance with FDA regulations can lead to detention issues, resulting in costly delays, reputation damage, and legal repercussions. This article aims to explore ten effective strategies to mitigate risks and minimize FDA detention issues, focusing on FDA labeling requirements as a critical aspect of compliance. By fostering a collaborative relationship with the FDA, companies can mitigate the risk of detention issues and facilitate timely resolution of regulatory issues. By fostering a culture of continuous improvement, companies can adapt to evolving regulatory requirements and minimize the likelihood of FDA detention issues. ConclusionIn conclusion, mitigating the risk of FDA detention issues requires a multifaceted approach encompassing regulatory compliance, quality assurance, risk management, and continuous improvement.
collect
0
FDA Consulting and the Global Production Chain
Tangeer Mehedi 2021-01-27
img

There is considerable evidence that the USA Food and Drug Administration (FDA) is continuing to aware of its home drug production rather than the global delivery chain that has spread over the latest years.

Many believed that 2008-2009 would see a shift inside the FDA's recognition from the finished product to the global production line consisting of the API or energetic component.

This is following the 2008 heparin Affair wherein infected doses of the blood thinner Heparin killed hundreds of people inside the US and UK.

To know more here about US FDA registration.The API in the infected Heparin had entered the United States from China and an excessive backlash from congress denouncing the effectiveness of the FDA turned into predicted to influence a brand new method to FDA consulting and rules.

The pharmaceutical enterprise anticipated the FDA to shift its focus far from the domestic completed product manufacturers and on to China and other distinguished suppliers of APIs.This argument follows the latest exam of FDA caution letters issued between 2008 and 2009.

Over 80% of them were issued to domestic pharmacy businesses helping the fact that the FDA nevertheless has a slim scope of motion.

collect
0
Everything You Need To Know About an FDA Notice of Action
Abady Law Firm 2023-08-09
img
Depending on the findings of the examination, the FDA may issue a Notice of Action. In this blog, we will discuss what an FDA Notice of Action is and how an experienced attorney like CustomsESQ/Abady Law Firm P. What is an FDA Notice of Action? The FDA district office then issues a “Notice of FDA Action. For more information about an FDA notice of action or for assistance with any of the issues noted above, contact Abady Law Firm, P.
collect
0
FDA Certification Singapore
ISO Certification 2022-01-27
img
The FDA registration allows the manufacturer to market their products in the US market. What is a FDA registration number? But, FDA approval is important for new drug products and critical medical devices to step into the business market. Companies that require FDA RegistrationFDA Certification is a must for the manufactures of:·        Drugs·        Food and beverages·        Dietary supplements·        Animal food·        Food supplements·        Food ingredients·        Color additives·        Medical devices·        Masks, gloves and gowns·        Also, analytical test facilities, etc. But, the cosmetic product manufactures or brand owners within the US can get this FDA registration voluntarily through the Voluntary Cosmetics Registration Program.
collect
0
What Are The Trustworthy Sources Of Donations To Israel?
Bezri 2024-10-13
img
Fundraising Events Raising funds through organized events such as auctions, charity walks or runs, and benefit concerts attracts high-profile sponsors and generates significant contributions. Direct Appeals Charity groups use direct appeals through personalized letters, emails, or phone calls to reach potential donors. They communicate their missions to individuals, corporations, and foundations and seek charity for Israel. With CSR, business organizations demonstrate their commitment to social causes by extending financial assistance to Israeli charity groups. Grant Applications Charity groups approach government bodies, private foundations, and international organizations for grants.
collect
0
Israel Aquaculture Market Analysis, Share, Size, Trends, Growth and Forecast
varunkp 2023-01-04
img
Browse over XX market data Figures spread through 70 Pages and an in-depth TOC on "Israel Aquaculture Market". The Israel Aquaculture market is segmented based on type, species, production, and distribution. Major companies operating in Israel Aquaculture market are:Aquaculture Production Technology (Israel) LimitedAquaMaof Aquaculture Technologies Limited. All the elements mentioned above impact market growth and create a favorable condition to propel the Israel aquaculture market growth until 2027. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in the Israel aquaculture market.
collect
0
WHO WOULD YOU CHOOSE FOR YOUR COURIER SHIPMENT MOVING FROM ISRAEL TO ENGLAND?
Kef International 2022-08-23
img
So, if you have a package to send to Israel or England, you can try the service of Kef International for your package moving from Israel. You can rely on us with your package as we are a dominant courier service in the market for all types of couriers from Israel, England, and moving to Israel. We count both inside and outside of our delivering products before packaging and unboxing to perfect the customer experience for moving to Israel and from Israel England. And many courier services charge a high cost for your couriers, but our courier service offers a promised delivery in a certain time and with your 100% satisfaction. So, contact us to try for the best service now and ensure you have to visit again the next time for another courier moving to Israel.
collect
0
Introduction to FDA Lawyer
mghcmku 2024-03-14
img
An FDA lawyer is a legal professional specializing in matters related to the Food and Drug Administration (FDA). Roles and Responsibilities of an FDA LawyerUnderstanding FDA RegulationsFDA lawyers must have a comprehensive understanding of the regulations set forth by the FDA. Knowledge of FDA RegulationsIn addition to legal expertise, FDA lawyers must possess a deep understanding of FDA regulations and policies. How to Find a Competent FDA LawyerResearch and ReferralsWhen seeking an FDA lawyer, it's essential to conduct thorough research and seek referrals from trusted sources. How can an FDA lawyer help with FDA inspections and audits?
collect
0
FDA Attorney: Your Guide to Regulatory Compliance and Legal Representation
cenoc33968@rehezb.com 2024-05-08
img
Understanding the Role of an FDA AttorneyWhat Does an FDA Attorney Do? An FDA attorney specializes in regulatory compliance, offering legal advice and representation to clients in industries regulated by the FDA. Frequently Asked Questions about FDA AttorneysHow do I know if my business needs an FDA attorney? The cost of hiring an FDA attorney depends on various factors, including the attorney's experience, the complexity of the case, and the fee structure. By understanding the role of an FDA attorney and following the guidelines outlined in this article, businesses can effectively navigate FDA regulations and safeguard their interests.
collect
0
Get Instant Medical Device Registration by FDA Listing Inc.
FDA Listing Inc. 2019-10-11
img

FDA Listing Inc. is top FDA US agent, who will help in the FDA device registration process and compliance with FDA rules.

We are available 24 hours a day to answer your questions via our Online Live Help.

collect
0
FDA Import Registration
activeskorts 2021-10-28
img

FDA Import Registration - Get Your Compliance Quickly.

Register your business with the FDA easily.

Register with FDA in 24 hours.

All-inclusive service for one-off fee.FDA Medical Device RegistrationFDA Food RegistrationFDA Registration RenewalUS FDA Agent

collect
0
How Is AI Optimizing Different Aspects of FDA Submissions?
Ingenious E-Brain Solutions 2023-04-28
img
Nowadays, companies are leveraging artificial intelligence for effective and quick submissions. · Traditionally, the FDA evaluates medical devices through a suitable premarket pathway, such as De Novo classification or premarket approval. The FDA’s traditional medical device regulation paradigm was not intended for adaptive artificial intelligence and machine learning technologies. Under the FDA’s current approach to software changes, the FDA anticipates that many artificial intelligence and machine learning-driven software modifications to a device need a premarket review. ” This explains the FDA’s foundation for a possible way to premarket review for artificial intelligence and machine learning-driven software modifications.
collect
0
Why Do Businesses Need Computerized System Validation
WCS Consulting Inc. 2021-07-13
img

One should not overlook this step as the consequences are not going to be so good.

Ignoring or avoiding computerized system validation can result in a great compromise to the integrity, putting the clients of the company on the line, datum corruption, and whatnot.Who Needs Computer Validation Services?Now that we have made it clear what computer validation is, let’s take a look at who all require it.

Before that, let’s make one thing clear, computer validation is so much more than reducing several risks related to business.For example, detecting the defects in medication will avoid serious problems such as unfortunate side-effects or any major problem that a customer or consumer could come across.

Thus, computer system validation is an immensely important stage for certain organizations.With that being said, let's have a look at some of the businesses, which are enforced legally for conducting CSV.Storage and Distribution Providers – It is vital for the businesses that store medications, cell and tissue products, biological, etc., to incorporate a computer validation system.

In case such companies fail to compete with the CSV, there will be strict penalties, which might be as severe as debarment or criminal prosecution.Medical Device Distributors – It is also obligatory for the business that stores medical devices to use a computer validation system.

What exactly are the medical device distributors?

collect
0
The FDA 510k Submission Process: What You Need to Know
Maven 2023-02-24
img
 Stages of FDA 510k process 1. The FDA 510k submission process can be complex and time consuming, so it is important to work with an experienced regulatory consultant to ensure that the submission is complete and accurate. The first step in the FDA 510k submission process is to create a device description. The FDA 510k submission process is an important step for any medical device manufacturer who wishes to sell their device in the United States. One-stop Solution for US FDA 510kMaven is one of the best regulatory consultants for the US FDA 510k services of your product.
Introduction to FDA Lawyer
mghcmku 2024-03-14
img
An FDA lawyer is a legal professional specializing in matters related to the Food and Drug Administration (FDA). Roles and Responsibilities of an FDA LawyerUnderstanding FDA RegulationsFDA lawyers must have a comprehensive understanding of the regulations set forth by the FDA. Knowledge of FDA RegulationsIn addition to legal expertise, FDA lawyers must possess a deep understanding of FDA regulations and policies. How to Find a Competent FDA LawyerResearch and ReferralsWhen seeking an FDA lawyer, it's essential to conduct thorough research and seek referrals from trusted sources. How can an FDA lawyer help with FDA inspections and audits?
10 Effective Strategies to Mitigate Risk and Minimize FDA Detention Issues
myfdalaw 2024-05-30
img
However, non-compliance with FDA regulations can lead to detention issues, resulting in costly delays, reputation damage, and legal repercussions. This article aims to explore ten effective strategies to mitigate risks and minimize FDA detention issues, focusing on FDA labeling requirements as a critical aspect of compliance. By fostering a collaborative relationship with the FDA, companies can mitigate the risk of detention issues and facilitate timely resolution of regulatory issues. By fostering a culture of continuous improvement, companies can adapt to evolving regulatory requirements and minimize the likelihood of FDA detention issues. ConclusionIn conclusion, mitigating the risk of FDA detention issues requires a multifaceted approach encompassing regulatory compliance, quality assurance, risk management, and continuous improvement.
FDA Attorney: Your Guide to Regulatory Compliance and Legal Representation
cenoc33968@rehezb.com 2024-05-08
img
Understanding the Role of an FDA AttorneyWhat Does an FDA Attorney Do? An FDA attorney specializes in regulatory compliance, offering legal advice and representation to clients in industries regulated by the FDA. Frequently Asked Questions about FDA AttorneysHow do I know if my business needs an FDA attorney? The cost of hiring an FDA attorney depends on various factors, including the attorney's experience, the complexity of the case, and the fee structure. By understanding the role of an FDA attorney and following the guidelines outlined in this article, businesses can effectively navigate FDA regulations and safeguard their interests.
FDA Consulting and the Global Production Chain
Tangeer Mehedi 2021-01-27
img

There is considerable evidence that the USA Food and Drug Administration (FDA) is continuing to aware of its home drug production rather than the global delivery chain that has spread over the latest years.

Many believed that 2008-2009 would see a shift inside the FDA's recognition from the finished product to the global production line consisting of the API or energetic component.

This is following the 2008 heparin Affair wherein infected doses of the blood thinner Heparin killed hundreds of people inside the US and UK.

To know more here about US FDA registration.The API in the infected Heparin had entered the United States from China and an excessive backlash from congress denouncing the effectiveness of the FDA turned into predicted to influence a brand new method to FDA consulting and rules.

The pharmaceutical enterprise anticipated the FDA to shift its focus far from the domestic completed product manufacturers and on to China and other distinguished suppliers of APIs.This argument follows the latest exam of FDA caution letters issued between 2008 and 2009.

Over 80% of them were issued to domestic pharmacy businesses helping the fact that the FDA nevertheless has a slim scope of motion.

Get Instant Medical Device Registration by FDA Listing Inc.
FDA Listing Inc. 2019-10-11
img

FDA Listing Inc. is top FDA US agent, who will help in the FDA device registration process and compliance with FDA rules.

We are available 24 hours a day to answer your questions via our Online Live Help.

Everything You Need To Know About an FDA Notice of Action
Abady Law Firm 2023-08-09
img
Depending on the findings of the examination, the FDA may issue a Notice of Action. In this blog, we will discuss what an FDA Notice of Action is and how an experienced attorney like CustomsESQ/Abady Law Firm P. What is an FDA Notice of Action? The FDA district office then issues a “Notice of FDA Action. For more information about an FDA notice of action or for assistance with any of the issues noted above, contact Abady Law Firm, P.
FDA Certification Singapore
ISO Certification 2022-01-27
img
The FDA registration allows the manufacturer to market their products in the US market. What is a FDA registration number? But, FDA approval is important for new drug products and critical medical devices to step into the business market. Companies that require FDA RegistrationFDA Certification is a must for the manufactures of:·        Drugs·        Food and beverages·        Dietary supplements·        Animal food·        Food supplements·        Food ingredients·        Color additives·        Medical devices·        Masks, gloves and gowns·        Also, analytical test facilities, etc. But, the cosmetic product manufactures or brand owners within the US can get this FDA registration voluntarily through the Voluntary Cosmetics Registration Program.
FDA Import Registration
activeskorts 2021-10-28
img

FDA Import Registration - Get Your Compliance Quickly.

Register your business with the FDA easily.

Register with FDA in 24 hours.

All-inclusive service for one-off fee.FDA Medical Device RegistrationFDA Food RegistrationFDA Registration RenewalUS FDA Agent

What Are The Trustworthy Sources Of Donations To Israel?
Bezri 2024-10-13
img
Fundraising Events Raising funds through organized events such as auctions, charity walks or runs, and benefit concerts attracts high-profile sponsors and generates significant contributions. Direct Appeals Charity groups use direct appeals through personalized letters, emails, or phone calls to reach potential donors. They communicate their missions to individuals, corporations, and foundations and seek charity for Israel. With CSR, business organizations demonstrate their commitment to social causes by extending financial assistance to Israeli charity groups. Grant Applications Charity groups approach government bodies, private foundations, and international organizations for grants.
How Is AI Optimizing Different Aspects of FDA Submissions?
Ingenious E-Brain Solutions 2023-04-28
img
Nowadays, companies are leveraging artificial intelligence for effective and quick submissions. · Traditionally, the FDA evaluates medical devices through a suitable premarket pathway, such as De Novo classification or premarket approval. The FDA’s traditional medical device regulation paradigm was not intended for adaptive artificial intelligence and machine learning technologies. Under the FDA’s current approach to software changes, the FDA anticipates that many artificial intelligence and machine learning-driven software modifications to a device need a premarket review. ” This explains the FDA’s foundation for a possible way to premarket review for artificial intelligence and machine learning-driven software modifications.
Israel Aquaculture Market Analysis, Share, Size, Trends, Growth and Forecast
varunkp 2023-01-04
img
Browse over XX market data Figures spread through 70 Pages and an in-depth TOC on "Israel Aquaculture Market". The Israel Aquaculture market is segmented based on type, species, production, and distribution. Major companies operating in Israel Aquaculture market are:Aquaculture Production Technology (Israel) LimitedAquaMaof Aquaculture Technologies Limited. All the elements mentioned above impact market growth and create a favorable condition to propel the Israel aquaculture market growth until 2027. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in the Israel aquaculture market.
Why Do Businesses Need Computerized System Validation
WCS Consulting Inc. 2021-07-13
img

One should not overlook this step as the consequences are not going to be so good.

Ignoring or avoiding computerized system validation can result in a great compromise to the integrity, putting the clients of the company on the line, datum corruption, and whatnot.Who Needs Computer Validation Services?Now that we have made it clear what computer validation is, let’s take a look at who all require it.

Before that, let’s make one thing clear, computer validation is so much more than reducing several risks related to business.For example, detecting the defects in medication will avoid serious problems such as unfortunate side-effects or any major problem that a customer or consumer could come across.

Thus, computer system validation is an immensely important stage for certain organizations.With that being said, let's have a look at some of the businesses, which are enforced legally for conducting CSV.Storage and Distribution Providers – It is vital for the businesses that store medications, cell and tissue products, biological, etc., to incorporate a computer validation system.

In case such companies fail to compete with the CSV, there will be strict penalties, which might be as severe as debarment or criminal prosecution.Medical Device Distributors – It is also obligatory for the business that stores medical devices to use a computer validation system.

What exactly are the medical device distributors?

WHO WOULD YOU CHOOSE FOR YOUR COURIER SHIPMENT MOVING FROM ISRAEL TO ENGLAND?
Kef International 2022-08-23
img
So, if you have a package to send to Israel or England, you can try the service of Kef International for your package moving from Israel. You can rely on us with your package as we are a dominant courier service in the market for all types of couriers from Israel, England, and moving to Israel. We count both inside and outside of our delivering products before packaging and unboxing to perfect the customer experience for moving to Israel and from Israel England. And many courier services charge a high cost for your couriers, but our courier service offers a promised delivery in a certain time and with your 100% satisfaction. So, contact us to try for the best service now and ensure you have to visit again the next time for another courier moving to Israel.