BiotechBistro Forums Tag: avellanet

BiotechBistro Forums Tag: avellanet http://biotechbistro.com/forum/tags/avellanet The Business of Biotechnology en-US Sat, 31 Jul 2010 00:42:17 +0000 bbpress 1.0-alpha-4 <![CDATA[Search]]> q http://biotechbistro.com/forum/search.php javellan on "Personalized Medicine and FDA Compliance Mix in New Book" http://biotechbistro.com/forum/topic/personalized-medicine-and-fda-compliance-mix-in-new-book#post-49 Tue, 04 May 2010 08:40:57 +0000 javellan 49@http://biotechbistro.com/forum/ Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine Published by Logos Press, and available nationwide through Barnes & Noble, Amazon.com, Borders Books, and other booksellers, Get Market Now! (342 pages, ISBN: 978-1-934899-12-0, softcover) is designed for executives in the life sciences, from pharmaceutical and biotechnology firms, to medical device and diagnostic companies. Readers of advanced copies have also suggested the book will be “an excellent resource for investors and venture capitalists who need to accurately assess if a company has what it takes in its research & development programs to succeed over the next ten years.” The book provides practical strategies to speed time to market and simply FDA compliance supported with analyses, advice and more than: • 25 figures, diagrams and tables • 15 different checklists and templates • 113 specific tactics • 16 case studies and real-world examples The book's readers also benefit from a dedicated book website - <a href="http://www.Get2MarketNow.com" rel="nofollow">http://www.Get2MarketNow.com</a> - full of downloadable templates, mini-tutorials, and more. Early reviews have cited the book for how well its writing and organization make complex, nuanced subjects easy to understand, from tackling the decline in new medicine innovation and R&D productivity, through increasing business flexibility while still complying with regulations. Journalists who would like a review copy of Get to Market Now!, should contact the publisher Logos Press directly in Washington, D.C.: <a href="mailto:info@logos-press.com">info@logos-press.com</a> or 202-487-0089. Author John Avellanet is the founder and Managing Director of Cerulean Associates LLC, a private regulatory compliance consultancy based in Williamsburg, Virginia. Mr. Avellanet has gained tremendous acclaim on his speeches, workshops and teleconferences for corporate clients and conference venues around the world. Enthusiastic testimonials from attendees cover his speaking page on his website. Conference organizers and program directors repeatedly note that he gets the highest evaluations of any of their speakers. He serves on the boards of several industry associations, and is the FDA compliance columnist for several international industry journals. Every month, he publishes the regulatory intelligence and FDA quality systems advice newsletter for executives, SmarterCompliance™. Learn more about Mr. Avellanet on his award-winning blog, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>. To engage his private consulting services for FDA-regulated firms, contact him through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> ### javellan on "FDA Compliance Experts on How to Avoid FDA and Courtroom Troubles" http://biotechbistro.com/forum/topic/fda-compliance-experts-on-how-to-avoid-fda-and-courtroom-troubles#post-26 Fri, 18 Sep 2009 13:26:59 +0000 javellan 26@http://biotechbistro.com/forum/ 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. 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 – just like Merck, GSK, AstraZeneca, Medtronic, and others – has document and email land mines that will emerge during litigation or an FDA inspection. When companies are is 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: <a href="mailto:mac@advamed2009.com">mac@advamed2009.com</a> 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 <a href="http://www.advamed2009.com" rel="nofollow">http://www.advamed2009.com</a>. 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, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>. To engage his private consulting services for FDA-regulated firms, contact him through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> ### javellan on "FDA Supplier Quality Management Congress this August" http://biotechbistro.com/forum/topic/fda-supplier-quality-management-congress-this-august#post-23 Mon, 13 Jul 2009 20:46:50 +0000 javellan 23@http://biotechbistro.com/forum/ A joint three-day conference on assuring the integrity of drug and device raw materials and supply chains will be hosted by FDAnews and officials from the US FDA, and chaired by Cerulean's Managing Director and co-founder, John Avellanet. Mr. Avellanet has been working with conference officials since earlier this year to line up a practical program to address current hot topics including: * Three case studies of quality agreements - what worked, what didn't, and why * Using process flow diagrams to identify critical control points in your supply chain and quality agreements with suppliers * FDA inspection tactics and enforcement trends * How to incorporate risk-based controls into supplier management procedures and policies * Overcoming language and global supplier barriers to promote effective management * How to use supplier audits to drive down risk and increase product safety Subscribers to Mr. Avellanet's monthly newsletter, SmarterCompliance, will recognize all of these topics from previous articles and presentations. The conference will be held August 19-21 in Arlington, Virginia, right next door to Washington, D.C. If you’d like to attend the conference and meet with officials from the FDA and top industry experts, visit <a href="http://www.fdanews.com/conference/detail?eventId=2783" rel="nofollow">http://www.fdanews.com/conference/detail?eventId=2783</a> for details. javellan on "Upcoming Book on Personalized Medicine & FDA Compliance" http://biotechbistro.com/forum/topic/upcoming-book-on-personalized-medicine-amp-fda-compliance#post-20 Fri, 05 Jun 2009 13:02:08 +0000 javellan 20@http://biotechbistro.com/forum/ Cerulean’s managing director, John Avellanet, has signed a contract with Logos Press to write a book covering the compliance and quality systems landscape over the next decade, including the compliance strategies required for new drug and device development and approval in the era of personalized medicines. Based in part on Mr. Avellanet's April talk at the NIH on the future of the biopharmaceutical landscape, and his SmarterCompliance newsletter series on personalized medicine and the role of regulatory compliance, the book provides a strategic review of the compliance and quality systems best practices required for marketplace success over the next decade for biotechnology, pharmaceutical, and medical device firms. The book is sub-divided into three parts: a review of today’s landscape, an analyses of the key challenges likely to dominate over the next ten years, and then a step-by-step strategy covering: • Faster product innovation and development • Medicinal safety and efficacy by design • Cost-effective, lean quality systems • Flexible, regulatory compliance programs As part of the book’s practical, “how to” mindset, readers will be able to access bonus materials, downloads, and supplemental information online through a dedicated book website. Subscribers to Mr. Avellanet’s monthly newsletter, SmarterCompliance, will be able to access pre-publication materials and downloads as part of the lead-in to publication. Publication is slated for May 2010. John Avellanet is the author of more than 100 articles, is the compliance columnist for several international industry journals, and is a former C-level biotech and medical device executive for a Fortune 50 subsidiary. As the co-founder of the private compliance advisory firm, Cerulean Associates LLC, he publishes the monthly executive 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, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>, or through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> ### javellan on "New FDA Compliance Blog Published" http://biotechbistro.com/forum/topic/new-fda-compliance-blog-published#post-19 Thu, 21 May 2009 12:58:50 +0000 javellan 19@http://biotechbistro.com/forum/ Cerulean’s managing director, John Avellanet, has finally given in and started a blog of basic FDA advice on quality systems and regulatory compliance: Compliance Zen. Compliance Zen is through TypePad at: <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a> Compliance Zen offers practical tips and short “how-to” articles on FDA-related topics such as Quality by Design, lean FDA compliance, records management, and Part 11 compliance. The blog also provides quick management and leadership tips gleaned from a mix of Mr. Avellanet’s personal experiences plus independent business management research. Included in the blog are reviews of leadership books with relevance to compliance, quality systems, and regulatory affairs executives (excerpted from his SmarterCompliance newsletter’s Featured Reading section). John Avellanet is the author of more than 100 articles, is the compliance columnist for several international industry journals, and is a former C-level biotech and medical device executive for a Fortune 50 subsidiary. As the co-founder of a private compliance advisory firm, he publishes the monthly executive 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 website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> javellan on "GxP Lifeline Interviews John Avellanet on Saving Money and FDA Compliance" http://biotechbistro.com/forum/topic/gxp-lifeline-interviews-john-avellanet-on-saving-money-and-fda-compliance#post-14 Wed, 18 Mar 2009 11:35:58 +0000 javellan 14@http://biotechbistro.com/forum/ In its March issue, GxP Lifeline interviewed Cerulean’s Managing Director, John Avellanet, on the FDA’s increasing concern about data quality, the new FDA Part 11, computer virtualization, and his private SmarterCompliance FDA advisory service for executives in the medical device, pharmaceutical and biotech industries. Executives awaiting news of FDA’s long delayed revisions to 21 CFR Part 11 would do well to subscribe to Cerulean’s FDA intelligence newsletter. As Mr. Avellanet pointed out, “Subscribers expect Part 11 to emerge from the agency this year, have a good feel for what the new Part 11 will include, and have already begun their preparations and project budgeting.” Computer virtualization is much more viable under the revised Part 11, according to Mr. Avellanet. Companies can save 30-80% from their IT budgets depending on how aggressively they pursue virtualization and how prepared they are for the new Part 11. Executives and business owners who participate in Mr. Avellanet’s SmarterCompliance program have gotten at least a 6-12 month drop on their competitors and the FDA’s own inspectors by incorporating Cerulean’s recommendations and insights. Mr. Avellanet said he was most pleased that “because of my constant insistence on cost-efficiency these past 3 years, my clients have been able to weather the current economic conditions quite admirably.” Cerulean has put a copy of the full interview on its website at <a href="http://www.ceruleanllc.com/resources" rel="nofollow">http://www.ceruleanllc.com/resources</a>\Part11_Saving_Money_Virtualization.htm, or readers may visit the GxP Lifeline site for the full March issue. Cerulean's SmarterCompliance program includes a monthly newsletter that mixes compliance and regulatory intelligence with specific recommendations, strategies and quality systems tactics executive teams can adopt. Cerulean surveys a broad set of information sources, including the FDA's own publications, warning letters, daily news, other governmental publications, blogs, and so on to synthesize the information that is then analyzed for subtexts, trends and themes. Journalists who would like a complimentary subscription to Cerulean's SmarterCompliance™ newsletter can contact Mr. Avellanet directly through the Cerulean website. Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and medical device sectors cut costs, streamline quality systems, speed new drug, biologic or device time to market, and protect their intellectual property from theft. Cerulean publishes the SmarterCompliance™ newsletter as part of its SmarterCompliance FDA executive advisory program. On the web at <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a>. ###