EMC Test And FCC Compliance Are Two Words to Keep in Mind For Electrical Device Manufacturers

EMC test and FCC compliance are two very common phrases for all those that are involved in the manufacture of electrical and electronic devices. It is common knowledge that these devices often produce radio frequency and this can have multiple harmful effects. Through testing and compliance a manufacturer can avoid such circumstances and release their products to the market in the shortest possible time. And this is important given the intense competition that is there in this industry.

What is EMC? This is one question many people tend to ask. EMC or Electromagnetic Compatibility is a science that deals with the unexpected generation, propagation and reception of electromagnetic energy. EMC certification is widely sought out by the manufacturing companies that produce wireless and medical equipment.

Along with EMC there is another phrase you will come across. This is called EMI or Electromagnetic Interference. It is a common phrase in the electronic product manufacturing industry where statute says that any electrical or electronic device shouldn’t interfere with another electrical or electronic device in its vicinity. EMI and EMC are tests that can be conducted easily by experts. Issues like radiated emissions and radiated immunity can be taken care of by EMI testing and EMC testing.

FCC or Federal Communications Commission is an independent US federal agency and it works in the areas of broadband, competition, homeland security, media, public safety and the spectrum. Any new product that is manufactured and that falls under these six categories need to comply with the relevant part of Title 47 of the US Code of Federal Regulations. FCC compliance is needed for all these products and without the compliance certificate the product cannot be released to the market.

While there are many requirements of FCC compliance, one of the most important among all is FCC part 15. This can be received after the compliance testing is done and the product clears the test. Like EMC test, FCC testing can also be done by an independent agency and they can help you get the certification for your product.

Why do you need EMC test and FCC compliance? The reason is rather simple to see – without EMC and FCC certificates your products cannot be legally released to the market. You spend thousands of hours and significant money and staff time to develop a product. It is but obvious that you would like to release it for sale ASAP so that it starts bringing in the revenue. When your product doesn’t clear these tests you need to wait for retesting. And retesting means more money and time lost. You wouldn’t want this, would you?

When you work with a professional agency for EMC test and FCC compliance you can rest assured that your time to market will be as low as possible. They not only prepare your product for the tests but also ensure that the initial problems are taken care of and there is no requirement for retesting.

EMC test and FCC compliance are absolutely required and you shouldn’t compromise with them at any cost.

Understanding The Importance And Functions of Reach Compliance

With the increasing competition in the market, the organizations into manufacturing products comprising of chemical substances have certainly lead to increase in pollution in the environment. It is not only harming people in many ways, but is also affecting the real beauty of our nature. But, with steps like REACH Compliance, things seem to be moving towards a new direction.

REACH is basically a new European Community Regulation on chemicals and their safe use. It targets at dealing with the Registration, Evaluation, Authorization and Restriction of Chemical substances. The law that came into force on 1st June 2007 has come up with an aim to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. At the same time, it also targets at enhancing the innovative capability and competitive of the EU chemicals industry.

The benefits of REACH software are very much palpable in the environment as it gives greater responsibility to the industry to manage the risks from chemicals and to provide safety information on the substances. Here, with its regulation, the manufacturers and the importers will be required to gather information on the properties of their chemical substances, which allow safe handling of them.

But, the biggest challenge is to understand and follow the legislation because it sounds confusing. In simpler words, REACH obligates manufacturers in the EU to ensure the chemicals it is using in excess of one ton annually are registered with a new central chemical agency set up in Helsinki and Finland. Here, the registration carried by the manufacturers includes supplying data such as chemical types and uses, volumes per annum and test data results.

It also compels companies importing products to ensure that the substances present inside those products are registered. However, if the manufacturer ensures that no one will be exposed to the substances during its use, including disposal, then it is not required to go for the registration.

The complexity of REACH compliance lies in its difference from nearly every company. For instance, each legal state has its different set of requirements and the company many also split into five legal entities each using less than one ton of a chemical per year. Moreover, it can also be done under one entity, in which case the tonnage is added together and falls under the scope of RACH.

So, look no further and move ahead in cleaning your environment and making it a chemical free place to live by getting a simple registration with REACH.

Defence For Disqualified Directors Orders

You may be experiencing the Insolvency Service laying the claim that one of your directors (or yourself) is a disqualified company director.

But it must prove that the director in question is unfit to continue with his or her duties. So anyone facing the prospect of being banned from continuing with their duties for a period of time should seek specialist legal advice.

Any proceedings for disqualified company directors are initiated under the Directors Disqualification Act 1986. It was this act which introduced the concept of unfit directors and their disqualification. The process is adversarial so it is always in director’s best interests to seek advice and representation from solicitors who specialise in disqualified directors cases.

There are various reasons why people may be ruled disqualified company directors. They might have allowed the business to continue trading while it was insolvent. This will have put any creditors at a severe disadvantage. They may have persistently breached legislation covering companies, such as by failing to keep proper books and records. A director may also be disqualified if he has allowed his company to use a prohibited name. Or he might have failed to co-operate with the company administrator or liquidator. Another reason for disqualification may be the fact that the director has failed to lodge tax returns or pay taxes due.

Whatever the reasons for people facing the prospect of becoming disqualified company directors, it cannot be overemphasised that the onus of proof is on those seeking disqualification. But this does not mean that those facing an order should just sit back. They need to pro-active and that means consulting with lawyers who deal with such cases.

If there is a defence against being named as a disqualified director the solicitor will help identify this. The defence will be put in a ‘Statement of Truth’ which will be put, under oath to the court. Defence witnesses may also be called. The aim is to dispel any suggestions that the director has been negligent in his duties, or is unfit to carry on his role in the business.

Even if, following consultations with the solicitor, that there is no realistic defence, there may be a chance to shorten the term of any disqualified directors ban by pleading there were mitigating circumstances. It is very important, if need be, that this course of action is followed as the consequences for disqualified company directors are so severe.

Disqualified directors cannot continue their role with their current company or form another one. Their names will also appear on the Disqualified Company Directors Register which is available to the public.

Online Will Kits Got Your Attention? Think Again!

Online advertisers are getting better with their lure of helping you make your will using cheap software or template will kits. Wills are not so trivial and you should take these more seriously. If it were a simple application or a draft of something not as significant, you could have easily relied on software, but much more is at stake here. A single mistake with the signature or a miscalculation with the most unassuming number can spoil all your hard work and make your intestate.

Advantage of Hiring Estate Lawyers

Estate lawyers give you highly personalized advice on your wills and estates, which you will never find with do-it-yourself kits. These kits advertise that anyone with a basic high school education can fill in the blanks and get their wills made, but what they hide is that someone with a high school education may not know much about state estate laws.

A will kit addresses the most common and mundane issues of a will. It does not provide for complications that may arise after your demise. To illustrate let us take the example of tax returns, if something does not pan out the way your will-kit provided for, then your benefactors will be at the deep end of the pool with a long legal battle ahead of them. In short, in an attempt to save a few hundred dollars you will push your family into the uncertainties of legal tussles.

To get all your loose ends in order you will require the professional service of an estate lawyer.

Without a real person to help you with your will, there cannot be peace of mind. Do-it-yourself kits come with no liabilities and will not bear any responsibility if the testator misinterprets a clause or makes the wrong choice for the lack of foreseeing the outcomes of his actions.

A common practice among users of such kits is to get their forms checked by Estate lawyers. The service of an estate lawyer does not come for free and the charges are just shy of a full blown will making session. Therefore, we think it is only wise to walk into the office of an estate lawyer and get your will made in the most professional manner possible.

How to Prepare For Manage And Follow up to an FDA Inspection – Webinar By Globalcompliancepanel

The FDA inspection is the most nerve-wracking event in the life of a regulatory professional – you’re in charge of compliance, usually in the background, and NOW you’re in the spotlight, and if your performance is not good, it is not the show that may close, it is YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA’s scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Areas Covered in the Session:

Who Will Benefit:

Price List:Live : $245.00Corporate live : $995.00Recorded : $295.00

webinars@globalcompliancepanel.com

Phone: 800-447-9407Fax: 302-288-6884

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he reviews and approves supplier qualification, selection, assessment, and CAPA. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.

GlobalCompliancePanel offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts & discussion forums.

GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Apart from providing excellent training to compliance professionals by compliance & consulting experts, GlobalCompliancePanel would also focus on providing:

EU Medical Device Classification – Webinar By GlobalCompliancePanel

Why should you attend : Today, medical devices occupy an extensive range of products that vary in intricacy and application. As the global market for medical devices continues to grow, it is important that companies be informed on the rules for classification of medical devices because of potential risk that can be associated with the device can have on the human body when used. This webinar will discuss the application of EU Council Directive on medical device classification.

Areas Covered in the Session

Basic definitions and purpose of medical device classification

How to carry out classification by reviewing the application and how to use the classification rules

Explanation of individual classification rules regarding non- invasive and invasive devises, along with additional rules applicable to active devices and other special rules

Who Will Benefit:

Quality Managers and Professionals

Marketing Managers and Professionals

Risk Managers and Investigators

R&D Project Managers and Team Members

Design Engineers

Consultants

Joy Frestedt, PhD, CCTI, RAC, FRAPS. Dr. Frestedt is the President and CEO of Frestedt Incorporated, a novel virtual Contract Research Organization network of over 50 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical and medical device industries especially running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and the development of quality systems to compete globally. She has held key positions including vice president of scientific, regulatory and clinical affairs at BridgePoint Medical and Humanetics Corporation as well as key management positions with Johnson and Johnson’s Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZenca Pharmaceuticals and Orphan Medical. Dr. Frestedt holds a B.A. in biology from Knox College and a Ph.D. in pathobiology from the University of Minnesota Medical School and she is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, American Society of Clinical Research Professionals and she is a Fellow of the Regulatory Affairs Professionals Society. Dr. Frestedt was named one of the “100 Most Inspiring People in the Life Sciences Industry (by PharmaVOICE, 2011) and one of the top 25 “Industry Leaders/ Women in Business Award (by the Minneapolis/St. Paul Business Journal, 2011).

GlobalCompliancePanelwww.globalcompliancepanel.comwebinars@

Click here for More Details

Phone: 800-447-9407 Fax: 302-288-6884

Why Compliance Management System is Important

The need for ethical business administration in a corporate environment is very crucial. Several key corporate issues such as company risk, governance and compliance are faced by companies. In the past, some firms have cared less for ethical administration and entangled themselves with several issues that have posed a threat to the economy. Companies don’t want to get trapped within such worrying issues and are more careful nowadays. Thankfully credentialing services provide them plenty of tools to manage their business effectively.

In the wake of the dwindling economy and growing concerns over corporate governance and compliance, many governments of first-world nations have unleashed stringent laws to monitor company operations. This gave companies more reasons to have a streamlined corporate governance system and so a strong emphasis on credential evaluation has been laid upon. Today, many businesses are investing in a compliance management system to ensure a bright future for their organizations. A good credentialing system helps businesses manage documents, licenses and certifications efficiently.

In order to tackle compliance issues, companies must first make themselves aware of the consequences of non-compliance. Along with managing business operations, companies often face the problems of managing documents related to corporate governance, risk and compliance. Managing these documents can be tiresome, thereby affecting the management and to some extent, the profitability of a company. Most companies now have a streamlined management system, thanks to credentialing services.

A compliance management system helps organizations stay compliant and manage employee credentials with ease. Companies have highly skilled employees whose licenses, insurance and certifications need to get updated regularly. A credentialing system helps companies keep all documents up to date and hence meet their compliance goals.

Companies that don’t have a proper compliance management system fail to keep all documents updated. This can lead to outdated or fraudulent employee credentials and can be a serious issue during audits. If law enforcers find any malpractices in an employee’s credentials, then the entire company might be held liable for such mismanagement, leading to serious consequences. Organizations investing in good credentialing services need not worry. They have an excellent web-based software program that manages their credentials and help them comply with all rules and regulations laid down by the corporate laws.

Securities Exchange Commission Brings 10b 5 Enforcement Action

The SEC filed securities fraud charges based on 10B-5 against Stiefel Laboratories Inc. (“Stiefel”), a manufacturer of dermatology products, and Charles Stiefel, the former chairman and CEO, alleging they defrauded stockholders out of over $110 million by repurchasing shares of company stock from current and former employees at undervalued prices and then selling the company for a 300% premium.

According to the SEC complaint, from November 2006 through April 2009, Stiefel repurchased stock through the company’s employee stock bonus plan. A third party valuation firm determined the share price. Stiefel allegedly failed to let the valuation firm know material, nonpublic information that should have been used in valuing the stock, including that five private equity firms offered to purchase the company’s preferred shares at valuations ranging from 50% to 200% higher than the price determined by the valuation firm as the fair market value. The failure to disclose, according to the complaint, resulted in an artificially low repurchase price. This led to Stiefel repurchasing shares at a discount. The repurchased shares were either cancelled or distributed to senior officers and employees, including the former CEO, and his two sons.

In July 2009, GlaxoSmithKline PLC (“Glaxo”) bought Stiefel’s outstanding shares for $2.9 billion. This was a 300% premium over the price per share paid by the corporation in connection with its share repurchase. Glaxo agreed to assume $400 million of the company’s debt and pay the company’s remaining shareholders another $300 million upon achieving certain performance milestones.

The complaint charged the company with violating, and Charles Stiefel with aiding and abetting the company’s violations of, Section 10(b) of the Securities and Exchange Act of 1934 (the “34 Act”) and its Rule 10b-5. Section 10(b) and Rule 10b-5 do not allow any act or omission resulting in fraud or deceit in connection with the purchase or sale of any security. It does not matter if the security is in a public or private offering. Potential penalties for violations include permanent injunctive relief, and being barred from serving as an officer.

You should consult with an experienced consumer fraud attorney if you become a victim of financial or other consumer fraud.

Pharmaceutical and Medical Device Good Manufacturing Practices Similarities and Differences

Why you should attend: As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs. You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems. An understanding of this paradigm shift can be gained by comparing the compliance based Pharmaceutical GMPs with the Medical Device Quality System Regulation. ICH-Q7A will be included because it is a cross between the quality and compliance approach.

Areas Covered in the Session:

Who Will Benefit:

Howard enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.Wednesday, November 23, 201110:00 AM PST | 01:00 PM EST

Examples and Explanations on When Community Property Terminates in Louisiana

While the previous article focused mainly on what the Louisiana Civil Code provides and a divorce attorney’s interpretation of the policy grounds therefore, this article seeks to explain the retroactivity of community property to the filing of a petition for divorce through several examples.

For the first example, let us say husband and wife have been married for several years before the wife felt as though she needed to speak with a divorce attorney about possible ending their marriage. The two had several children together, two of which were over the age of eighteen (age of majority in the state of Louisiana) and one of their children was fourteen years old (a minor). The spouses were living in a home in Metairie, Louisiana, which they had lived in for seven years and which they were living in at the time that the wife’s divorce attorney filed to end the marriage. The wife is a successful business executive making hundreds of thousands dollars a year and the husband is primarily responsible for raising the children of the marriage. In the above example the wife’s divorce attorney files under Louisiana Civil Code Article 102, meaning that the parties must live separate and apart, without reconciliation (which may be defined as the mutual intent to resume the marital association) for three hundred and sixty five days.

While the marriage is pending dissolution the wife is comforted in the fact that any money that she earns after filing is her separate assets. This encourages the wife to continue working during these stressful times. Moreover, because it will likely take one year to end this marriage of living separate and apart, the wife’s divorce attorney files to terminate the community property of the marriage retroactively to the date of filing under Louisiana code article 2374 which provides that a judgment decreeing separation of property may be entered after a filing of the petitions and after the parties have lived separate and part without reconciliation for more than thirty days. This may have to be done by contradictory hearing.

More than anything else, the above illustrations serves as a tremendous reminder to both the layperson and the practitioner alike, that there in fact rules and regulations which govern even ostensibly simple procedures such as an article 102 divorce. Furthermore, a divorce attorney can easily tell from this example the policy makers and law writers of Louisiana exhibited foresight before drafting these legal requirements. As I have summarized above, this law gives the working spouse an incentive to keep working and putting food on the table for his or herself, and to keep generating economic activity.

The above is provided as general information on the law — this is not legal advice. Please consult with an attorney for any legal questions. William H. Beaumont. New Orleans and Metairie, Louisiana.