FDA Medical Device Experts on How to Avoid FDA and Courtroom Troubles
Two FDA compliance experts will offer an executive workshop on how to ensure your internal company documents actually reflect your company’s commitment to product quality and patient safety, and the policies you’ll need to meet FDA requirements and reduce your risk in a lawsuit.
Williamsburg, VA, September 20, 2009 --(PR.com)-- Former FDA prosecutor, Nancy Singer, and former medical device company chief information officer, John Avellanet, will present Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails.
Consider attending this pre-conference Executive Workshop (free to all AdvaMed 2009 registered conference participants and their guests) because your firm has document and email land mines that will emerge during litigation or an FDA inspection.
When companies are investigated by the FDA or sued by angry patients or investors, phrases from emails are often taken out of context and leaked to the press. The negative coverage then embarrasses the company and its employees, not to mention undermining financial projections (KV Pharmaceuticals stock dropped more than 30% upon news of an FDA investigation).
During this session, Mrs. Singer will demonstrate how to teach your employees to create documents that will reflect your commitment to quality. Mr. Avellanet will provide a roadmap for managing company records in a compliant manner.
In addition, Marlene Bobka of FOI Services will explain what documents competitors can obtain about their competition from the FDA under the Freedom of Information Act. And then Mike Jovanis of Sparta Systems, will talk about implementing an electronic document management system to help further minimize risk and control documents.
To attend this pre-conference Executive Workshop send an email to: mac@advamed2009.com no later than October 1, 2009, and indicate that you plan to attend the Dangerous Documents Executive Workshop.
Journalists should also contact mac to obtain press passes.
The AdvaMed 2009 conference will be held October 12-14 in Washington, D.C. Choose from more than 40 panels in 10 areas of innovative medical technology. To view the panels or register for AdvaMed 2009, visit www.advamed2009.com.
Mr. Avellanet has gained tremendous acclaim on his speeches, workshops and teleconferences for various companies and venues around the country. Enthusiastic testimonials from attendees all over the world cover his speaking page on his website (http://www.ceruleanllc.com/Speaking.htm). Conference organizers and program directors repeatedly note that he gets the highest evaluations of any of their speakers. In addition to AdvaMed workshop, you can see Mr. Avellanet at the 8th Annual Pharmaceutical Contracting and Outsourcing Conference in New Jersey or as he runs a workshop on making compliance training enjoyable at the 4th Medical Device Regulatory, Reimbursement and Compliance Congress in Washington, D.C.
John Avellanet is the author of more than 100 articles, is the FDA compliance columnist for several international industry journals, and is the co-founder of the private compliance advisory firm, Cerulean Associates LLC. Every month, he publishes the regulatory intelligence and quality systems advice newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his blog, http://www.ComplianceZen.com. To engage his private consulting services for FDA-regulated firms, contact him through his company’s website: http://www.ceruleanllc.com
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Consider attending this pre-conference Executive Workshop (free to all AdvaMed 2009 registered conference participants and their guests) because your firm has document and email land mines that will emerge during litigation or an FDA inspection.
When companies are investigated by the FDA or sued by angry patients or investors, phrases from emails are often taken out of context and leaked to the press. The negative coverage then embarrasses the company and its employees, not to mention undermining financial projections (KV Pharmaceuticals stock dropped more than 30% upon news of an FDA investigation).
During this session, Mrs. Singer will demonstrate how to teach your employees to create documents that will reflect your commitment to quality. Mr. Avellanet will provide a roadmap for managing company records in a compliant manner.
In addition, Marlene Bobka of FOI Services will explain what documents competitors can obtain about their competition from the FDA under the Freedom of Information Act. And then Mike Jovanis of Sparta Systems, will talk about implementing an electronic document management system to help further minimize risk and control documents.
To attend this pre-conference Executive Workshop send an email to: mac@advamed2009.com no later than October 1, 2009, and indicate that you plan to attend the Dangerous Documents Executive Workshop.
Journalists should also contact mac to obtain press passes.
The AdvaMed 2009 conference will be held October 12-14 in Washington, D.C. Choose from more than 40 panels in 10 areas of innovative medical technology. To view the panels or register for AdvaMed 2009, visit www.advamed2009.com.
Mr. Avellanet has gained tremendous acclaim on his speeches, workshops and teleconferences for various companies and venues around the country. Enthusiastic testimonials from attendees all over the world cover his speaking page on his website (http://www.ceruleanllc.com/Speaking.htm). Conference organizers and program directors repeatedly note that he gets the highest evaluations of any of their speakers. In addition to AdvaMed workshop, you can see Mr. Avellanet at the 8th Annual Pharmaceutical Contracting and Outsourcing Conference in New Jersey or as he runs a workshop on making compliance training enjoyable at the 4th Medical Device Regulatory, Reimbursement and Compliance Congress in Washington, D.C.
John Avellanet is the author of more than 100 articles, is the FDA compliance columnist for several international industry journals, and is the co-founder of the private compliance advisory firm, Cerulean Associates LLC. Every month, he publishes the regulatory intelligence and quality systems advice newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his blog, http://www.ComplianceZen.com. To engage his private consulting services for FDA-regulated firms, contact him through his company’s website: http://www.ceruleanllc.com
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Contact
Cerulean Associates LLC
John Avellanet
757.645.2864
www.ceruleanllc.com
John Avellanet
757.645.2864
www.ceruleanllc.com
Contact
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