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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


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).


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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.

The Impact of Environmental Law Appears to be That Carbon Labelling Will Become Commonplace

Carbon labels which are ahead of products environmental impact are quietly spreading. Consumers may not yet have notice it, but there is a lot going on behind the scenes. Do you look for carbon footprint labels on goods when your shopping? If you do, you are in a small minority. The practice of adding labels to foods and other products should quantity of carbon dioxide emissions associated with making and transporting them began in 2007 when the world's first such labels replied to a handful of products sold in Britain. The idea was to cover levels would let shoppers identify products the smallest carbon footprints just as other labels already indicate dolphin friendly tuna, organic milk will be a trade coffee. Producers would compete to reduce carbon footprints of their products and consumers would be able to tell whether for example, locally made goods really were greener than imported ones.

Carbon levels have yet to become as widely recognised by consumers as other eco-levels, however. A survey carried out in 2010 by British consumer group found that just this British shoppers recognise the carbon footprint labels, compared with recognition rates of 82% fair trade in 54% for organic labelling. This is understandable because carbon labelling is much more recent development and organic labelling dates back to the 1970s and fair trade late 1980s and the right ways to do it are still being worked out. Adding a Carbon labels were product is a complex and often costly process that involves tracing its ingredients back of their respective supply chains and through the manufacturing process to work out their associated missions. According to 3,000,000, an American industrial giant makes and 55,000 different products this can cost $30,000 for a single product. To further confuse matters, different carbon footprint in the labelling standards have emerged in different countries preventing direct comparisons between the various types of labels.

Even so, proponents of carbon levels now see encouraging signs of progress. In Britain, a pioneer in carbon labelling, 9/10 households or products with carbon levels last year albeit mostly unwittingly in total sales of such products exceeded 2 billion. This exceeded the total sales of organic products or fair trade products and is largely due to the addition by Tesco, British industry's biggest retailer of carbon levels to more than 100 of its own brand products including parser, milk or in the orange juice and toilet paper. Tesco said it does and seven that it would put carbon levels and every one of the 70,000 products sells so far is managed to label 500 products. in last 12 months carbon footprint and has become a common currency says Harry Morrison of the Carbon trust which is a consultancy funded by the British government which is footprint of more than 5000 products worldwide, from building materials to pharmaceuticals. Similar carbon labelling initiatives to be launched in many countries and measurement techniques are gradually being formalised in a global standard is in the works. Although consumers have yet to embrace the idea, but quite spread of carbon labelling is being driven by companies which have come to see the value of determining the Carbon footprints of their products.

The Power of Law And Its Practitioners

The judicial structure in India is of three tiered nature. The first step is the district courts which are situated in various districts of India. Delhi was recognized as a distinct legal entity by the Proclamation Notification no. 911 on 17.09.1912. By the proclamation it came under the management of Governor General of India in council. The first Chief Commissioner of Delhi became Mr. William Malcolm Hailey, C.I.E., I.C.S. After this, for enforcing the existing laws in Delhi, the Delhi Laws Act, 1912 was enacted.

Part V, Chapter IV of the Constitution of India establishes The Supreme Court of India as the highest judicial forum. It is the final court of appeal, situated in Capital of India- New Delhi. Supreme Court acts as the watchdog of our constitution. The Supreme Court deals with two kinds of jurisdiction: original jurisdiction and appellate jurisdiction.

Under original jurisdiction of Supreme Court falls, disputes between states, or union and states and petitions involving infringement of fundamental rights. It also takes up appeals against the judgments of High Courts.

The 1961 law minister Ashoke Kumar Sen, was instrumental in passing of the Advocates Act. The Bar Council of India is responsible for its administration and enforcement. According to this act, Bar council of India is the supreme body to regulate the legal profession in India. In addition to being professionals, advocates are also officers of the courts. A vital role is played by them in the administration of justice. Advocates Act thus is a set of rules which should bind the law bearers and remind them of the duty they have towards the court, their clients and fellow advocates. advocates in delhi also abide by these rules and regulations.

There is a two fold process for being entitled to practice in India. The first step is that the applicant must be a law graduate from a recognized institution. The lists of such institutions are maintained by Bar Council of India for which it maintains an Internal Committee. In the second step, the law graduate to qualify as an advocate has to qualify the enforcement criteria laid by the council. Thus all the delhi advocates have also gone through the same two fold process.

Apart from the central Bar Council of India, there exists in each state a separate Bar council. Advocates are to register themselves with the bar councils and have to observe territorial confinement. However, registration doesn't restrict the advocates to appear in any court of India. Thus Delhi advocates can appear in Chennai high court or Guwahati high court.

In India, all advocates are recognized at the same level. Seniority is the basis of conferral of the title of senior advocate, which is on the basis of the duration of practice. Other factor affecting it is specialization in a particular field of law by the advocates. Apart from fame and status the Senior Advocates are requi8red to maintain higher standards of discipline, apart from some distinct rules. The senior advocates in Delhi also are bind to follow higher standards of conduct. Also they cannot interact directly with clients. From 2010 onwards lawyers are to pass the AIBE (All India Bar Exam) to qualify as an advocate. As a result advocates in Delhi, who passed from 2009-10 onwards have mandatorily passed the AIBE.

For an advocate to be appointed as a judge in high courts and Supreme Court, he/she must be having an experience of practicing law for at least ten years at high court or Supreme Court.

How FDA Trains Its Investigators to Review Capa And What You Should Do to Prepare

Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.

Areas Covered in the Session:

Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

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:

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


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

Reprocessing Reusable Medical Devices Cleaning and Labeling Requirements

Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices.

However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical devices.

Why should you attend: Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility. Failure to prove sterility in almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own medical device. If intended to be re sterilized by the user facility, cleaning & sterilization instructions must be precise and validated.

Areas Covered in the Session:

Who Will Benefit:

John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.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:

Wednesday, December 7, 201110:00 AM PST | 01:00 PM ESTPrice List:Live : $245.00Corporate live : $995.00Recorded : $295.00

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

Get I-9 Compliance Help From Only an I-9 Attorney

Do you know that all employers now working in the United States of America must prove their identities and eligibilities? Yes, it has become a law according to The Immigration Reform and Control Act. This act also brings certain changes in the I-9 compliance form that must be known to all US employers. If it's been several years that you have been running an organization with a good lot of employees on the US soils, you must have your I-9 compliance form ready having filled up correctly. Well, if you are not aware of The Immigration Reform and Control Act, you can always take assistance from an I-9 attorney.

When it comes to taking I-9 compliance help, an I-9 attorney can play a key role. Every US employer must be aware of the rules that have been made more rigid by the U.S. Immigration & Customs Enforcement (ICE). In this respect, these legal experts can help you understand all the laws and regulations of the act and make you aware of all such complications that might affect your employment status.

Moreover, one might face problems in filling up an I-9 compliance form. A slight error in the form can bring obstruction in the authentication proceedings. Therefore, I-9 lawyers will help you fill up these forms correctly and let you tackle any sort of legal issue with ease. Now, many employers might have questions as to why it's necessary to seek for I-9 compliance help.

The Department of Homeland Security or the Department of Labor or the Office of Special Counsel for Unfair Immigration can approach anytime to check whether an employer is legally fit to run an organization. In this respect, it's the I-9 compliance form that will act as the evidential document proving that you are an authenticated employer and allowed to work in the US. Therefore, I-9 compliance help is crucial that can keep you miles from any sort of hassle faced in the midst of the verification process.

Prior to contacting an I-9 attorney, it's important for you to know about those who are eligible for I-9 compliance help. Those getting re-employment after three years from the actual date; those employed since November 1998 and serving the organization since June 1986; and those employed prior November 1986 and still working in the company. Once you have confirmed all these facts, you can now seek for I-9 compliance help from an attorney.