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.

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:

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.

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.

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

webinars@globalcompliancepanel.com

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