Regulatory Compliance Consulting

Read more

As food distribution chains are increasingly stretched around the world, urgency has arisen for the creation of new food safety standards and stricter enforcement of existing food safety laws to ensure that food industry quality control and food processing standards provide for a safe global food supply.

The global food and beverage industry is the world’s largest industry. In fact, it is larger than all of the world’s other industries combined. In the quest for market share and increased profits, quality and food safety may sometimes be sacrificed. Consumers depend upon the interaction and the cooperation between government agencies to set and enforce standardized safety guidelines and food safety laws that ensure that there are no compromises in terms of quality and safety. Consumers need to know that produce from agriculture is safe from farm through processing to grocery shelves, that fish is safely wild harvested or raised by aquaculture, that poultry and livestock are free from pathogens and that food and food supplements contain ingredients generally recognized as safe. Processed foods must be pasteurized or sterilized, and canned or otherwise packaged aseptically sealed containers. Fresh food must be inspected by government agencies.

Coordinating those International Governmental efforts is no easy task however. In the United States alone, Food Safety Regulations are divided among multiple government Agencies such as the U.S. Food and Drug Administration (FDA), The U.S. Department of Agriculture (USDA), and the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB). These U.S. agencies must then communicate with the equivalent Government Agencies of other countries.

Food Safety Regulations and Compliance Information at www.fdaregistrar.com

In this complex maze of food safety regulations, it is beneficial for food and beverage companies throughout the world to have one central organization to assist them with FDA food safety guidelines. FDA Registrar Corp helps companies comply with the U. S. food and beverage safety laws that are required of companies doing business in the USA. These services are particularly helpful to non-U.S. companies that may need to overcome language barriers, time barriers and cultural barriers with regard to U.S. FDA requirements.

FDA Registrar Corp assists U.S. and non-U.S. companies with the completion of FDA regulations in the Food and Beverage, Medical Device and Cosmetics Industries. At www.fdaregistrar.com registration and compliance is quick and easy. FDA Registrar Corp’s food safety consultants, medical device experts and cosmetic specialists all make compliance procedures simple and affordable.

FDA Registrar Corp quickly helps companies with all of the following regulatory requirements based on FDA food safety guidelines thus improving relations with global trading partners:

Compliance with U.S. FDA Food Facility Registration

*U.S. Prior Notice (Forms to ship food and beverages to the USA)

*U.S. Food Labeling Regulations

*U.S. Food Canning Establishment Registration (FCE) and Process Filings (SID)

*U.S. FDA Medical Device Establishment Registration

*U.S. FDA Medical Device Listings

*U.S. FDA Cosmetic Registration

*U.S. FDA Cosmetic Formulation Filings

FDA Registrar Corp was organized in response to the U.S. FDA Bioterrorism Act of 2002 that required all companies involved with the manufacturing, processing, packaging and storing of food and beverages to be consumed in the United States, to register with the U.S. Food and Drug Administration and to adhere to FDA food safety guidelines. FDA Registrar Corp is the world’s largest FDA Agent assisting some of the Industry’s best-known companies with food safety regulations. With a systematic and conscientious approach, FDA Registrar Corp has helped all parties work towards providing food industry quality control standards to provide safe handling, storage and preparation of food and beverage products.

Read more

Standardized testing has become the archetype of public education in the United States, and the results are generally accepted as valid assessment of educational accomplishment. With an increase in standardized testing the pressure to raise scores begins, which in turn can lead to score pollution, which alters the validity of test score results. Standardized tests are based in behaviorist psychological theories from the nineteenth century. While our understanding of the brain and how people learn and think has progressed enormously, tests have remained the same. Behaviorism assumed that knowledge could be broken into separate parts and that people learned by passively absorbing these parts. Today, cognitive and developmental psychologists understand that knowledge is not separable parts and that people (including children) learn by connecting what they already know with what they are trying to learn. If they cannot actively make meaning out of what they are doing, they do not learn or remember. But most standardized tests do not incorporate the modern theories and are still based on recall of isolated facts and narrow skills. (Fairtest.org, 2006). Should standardized tests be used to assess the quality of educators and/or the success of schools? There are two possible answers: The tests and testing methods are suitable, or the use of standardized tests should be evaluated and changed.

Read more

FDA’s approval process for the products it regulates, are as varied as the products themselves. These differences are dictated by the laws FDA enforces and the relative risks that the products pose to consumers. FDA aims to provide ’safe and effective’ products to the consumers. From product testing to label scrutiny, FDA tests almost every aspect of food and drugs in order to ensure that they are ’safe and effective’ to use.

It might have never crossed your mind that most of the products that you use throughout the day are regulated by FDA. The Label on the juice can you lift for the morning breakfast, the cosmetics you apply to your latest hair color or the pain relief medicine that you take are all, FDA approved. With FDA approved goods, you can be sure that you are not being fooled by the deceptive ingredients on the label of the product. FDA approval process makes sure that the tested materials are used in the production of the goods, be it drugs, cosmetics or food items.

At FDA, the motto is to ensure consumer’s safety and satisfaction with the daily drugs and food that they consume. FDA however follows a strict mission, tracking the following four roles according to the Food and Drug Modernization Act:

*To promote health by reviewing research and approving new products.

*To ensure that foods and drugs are safe and properly labeled.

*To work with other nations to ‘reduce the burden of regulation’.

*To cooperate with experts and consumers to effectively carry out these obligations.

Companies need to have food licenses before they sell the food products in the US markets. Some products such as new drugs and complex medical devices must be proven safe and effective before they can be FDA approved. Also, FDA approves new food additives (a food license per se) before they can be used in food production. Other products such as X-ray machines and microwave ovens must measure up to performance standards. And some products such as cosmetics and dietary supplements can generally be marketed without prior FDA approval.

At the heart of FDA approval of medical products is a judgment about whether a new product’s benefit to users outweigh its risk. No regulated product is totally risk-free, so these judgments are important.

Expert guidance and easy procedure

FDA Registrar Corp undertakes the registration, U.S. Agent and compliance assistance to companies working in food & beverage, cosmetic and medical device sectors. Giving professional and expert assistance, FDA Registrar Corp makes the whole FDA approval process easy and speedy through it three-step procedure. Also, having worldwide network of offices, it takes extreme caution and care in the compliance procedures.

The rising awareness of costumer’s have made FDA a symbol of reliance and trust. Every product that comes in the market with FDA approval, is bound to be trusted. FDA approvals thus become important for all the food and drugs companies.

In brief, FDA approval process ensures that the product’s ingredients are safe in use and the labels show the actual ingredients and does not make false claims. For this the products undergo strict testing under a set rules and prescriptions. Approval from FDA is not only beneficial for the consumers, but also imperative for the manufacturers before their products enter the market.

Read more

Read more

Since the well publicised events surrounding the collapse of Barings Bank, Enron, WorldCom, and other high-profile financial disasters – both in the US and internationally - an increasing array of legislation has been put in place to try to mitigate the future risk of a repeat of these catastrophic (in the business context) events.

In the US, the Sarbanes Oxley Act of 2002 demanded a much greater level of accountability for Directors and in the UK, similar demands of business stakeholders were made through the Combined Code on Corporate Governance originally published in 1998 (revised 2003) and in the revised Companies Act 2006.

The result has been a significant increase in corporate cost, both in terms of in-house operational and management costs as well as external Audit, Consultancy and other specialist fees to achieve and maintain compliance. A substantial portion of this cost has been as a result of defining and implementing additional, time-consuming (and often manual), control processes, review structures, and certification processes all geared toward the provision of documentary evidence of control around the processes organisations already had in place. Having achieved compliance first time round, the number of organisations electing to replace these manual control processes with technological, best of breed, process automation and improvement tools has increased significantly. Few more so than in the area of GL account control, reconciliation and certification.

Today, the vast majority of organisations world-wide still rely heavily on (Excel) Spreadsheets to manage this critical process. Spreadsheets are used to accept a download of accounts from the GL; to track responsibility for ownership of the reconciliation and review; to track the completion of the reconciliation, review, and sometimes Approval, of each reconciliation; to track queries (open reconciling items); and to attempt to aggregate the value and categorisation of those open reconciling items for the purposes of assessing materiality.

Specialist (Web-based) tools for the automation of the GL account certification process have been developed (resulting in the elimination of Spreadsheets from the process). These tools are comprehensive, encompassing reconciliation preparation, review/approval, quality assurance testing (Audit), aggregation of open reconciling items, reporting and improved program management. The solutions are starting to make major inroads in helping organisations with thousands (to hundreds of thousands) of GL accounts to finally take complete control of the process - whilst driving real monetary benefit through efficiency and time-saving at the same time as ensuring compliance.

Organisations with a distributed National or International infrastructure are particularly well suited to this type of Web-based technology that provides for global visibility into the status of the reconciliation program.

For more information contact Ted Sparrey.

Read more

Read more

When you are dealing with collection agencies the first thing to understand is that not all of them are like the ones you see in the debt counseling commercials. Some are respectful of your rights under the law. Others however are the polar opposite and they will use illegal tactics to get you to pay. Basically, these tactics are the use of threats and harassment.

A good collector from your viewpoint is one that asks if you have the means to pay your debt in a nice manner. This collector will go over a list of options to see if you have any of these means at your disposal. This collector will try to work with you, allowing you to pay an amount each month that you can afford and will not report you to the credit bureaus. After you’ve paid the bill down some, this collector may offer you a settlement.

Usually, from the collection agencies point-of-view this collector isn’t performing up to the standard it wants and your case may be turned over to a more aggressive collector. The more aggressive collector will try to squeeze all he can from you. But as long as you pay the agreed upon amount on time every month, you’re within legal bounds.

In the case of credit card debt, your account can go from one collection agency to another as they sell off what they consider uncollectible debt. So you may find yourself dealing with different agencies over a period of time.

No matter what agency is calling you, you can ask them to call you when it’s more convenient for you. For example, if you work the midnight shift and don’t want calls early in the day. This request is within your legal rights. It’s also better for the collector to keep you more willing to cooperate.

The bad collector from your viewpoint is one that demands immediate payment in full and isn’t willing to work with you. He will tell you he is going to call you until you pay no matter how many calls it takes. This collector may scream at you and curse you. He may be argumentative with your family members hen they answer the phone.

This collector may be setting you up to play good cop and bad cop. If so, after a few calls, his manager will call you and sympathize with you concerning the way the collector treated you. He will also call and hang up and make threats.

They may want to keep your credit card on file for a payment each month or a record of your bank account. But a good collector will call you and ask for the payment and see if you still want to pay by credit card or online check.

If you want to pay with money order or check by mail, then a good collector will give you the address so you can make your payments this way.

Read more

Read more

When the collector calls you an excessive amount of time per day that is one form of harassment. This harassment can be stopped. You have protection under the law against certain abusive tactics that some collection agencies employ.

In the state of Texas, business solicitation calls can not be placed before 8 am or after 8 pm your time. That means that if a collection agency calls you before or after those hours, its harassment. You have the legal right to hang up under this condition.

Another common ploy they use in harassment is to threaten you. This is very serious harassment. These are some of the types of verbal threats they may use against you: saying that they will send out a police officer, or telling you they will freeze your accounts. Any statement that they make like this has to be lawful and they have to really intend to take action. If you receive this treatment you should check the federal and state laws to see if they can make the threat good.

The government is the only “person” able to freeze your accounts. Don’t believe a collector when he tells you he can do this. They may claim to be a lawyer and they better be one if they say they are. Otherwise, the collector has violated a federal law. They use this tactic because it sounds very serious and will intimidate a lot of debtors. Don’t let them intimidate you into forfeiting your right to being treated correctly under the law. Do learn about your rights.

They would have to have filed a warrant and have a court order to bring you in from your home, which is usually not an option for them to exercise.

The most basic way to stop harassment is to place a privacy manager on your phone. If anyone with an 800 number or other specific identity you don’t want calling you calls, then you can set it to make them go through a recorded announcement before they reach you. You can also use caller ID to help screen your calls.

If you want to find more legal options for yourself, you can contact a lawyer in your area or look up the information on the internet. The first law to look for is The Fair Debt Collection Practices Act. You may have the grounds for a lawsuit.

Before the collector can try to collect the debt, he must state that it’s an attempt to collect a debt and any information attained will be used for that purpose. He also has to tell you that the call may be recorded.

You can record the collection calls too. Recording the calls is a good measure to take to protect yourself in case the collector is verbally abusive, such as screaming at you, or cursing you. If you do want to record them then you have to tell them you’re recording the conversation so it will be admissible evidence of harassment in court.

Learn the federal and state laws concerning the collection of debts laws. That way you know what the collectors can legally do when attempting to collect a debt.

Read more