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

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.