BiotechBistro Forums Tag: FDA compliance

BiotechBistro Forums Tag: FDA compliance http://biotechbistro.com/forum/tags/fda-compliance The Business of Biotechnology en-US Sat, 31 Jul 2010 00:40:22 +0000 bbpress 1.0-alpha-4 <![CDATA[Search]]> q http://biotechbistro.com/forum/search.php javellan on "Protect Yourself from New FDA Enforcement Rules" http://biotechbistro.com/forum/topic/protect-yourself-from-new-fda-enforcement-rules#post-25 Wed, 26 Aug 2009 18:46:07 +0000 javellan 25@http://biotechbistro.com/forum/ In response to FDA Commissioner Hamburg's new "get tough" approach to regulatory enforcement, Cerulean’s managing director, John Avellanet, has revised his popular Bulletproof Yourself against FDA Enforcement webinar with more analyses, more trending information, and dozens more specific recommendations. Mr. Avellanet will host an encore presentation of this webinar and teleconference on Tuesday, September 29th. With the FDA taking significant steps to tighten its enforcement going into 2010, pharmaceutical, device, and biologics executives will not want to miss this newly updated online seminar. As the FDA transitions to enforcing its new 15-day deadline for companies to respond to Form 483 inspectional observations, warning letters will come fast and furious. New congressional authority for FDA plus new funding allocation promises more consent decrees. Mr. Avellanet will speak on the hot topics that FDA is expected to focus on over the next 15 months, how to lower your company’s risk of non-compliance, and what to do when the FDA inspector shows up. New topics Mr. Avellanet will touch upon for this revised encore talk include: • 5 keys to successfully responding to 483s in 15 days or less • Supplier due diligence aspects inspectors look for • What FDA inspectors expect to see when assessing your CAPA processes • Lessons you can apply from recent FDA consent decrees Register soon. Last year this talk filled up within 3 weeks of its announcement. The online seminar is limited to just 24 attendees to allow for more Q&A. You can register online here: <a href="http://www.ceruleanllc.com/Webinar/default.htm" rel="nofollow">http://www.ceruleanllc.com/Webinar/default.htm</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 the webinar, you can see Mr. Avellanet at the 8th Annual Contracting and Outsourcing Conference in New Jersey or as he runs a workshop on defensible documents at the AdvaMed MedTech Conference in October. 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 "New Webinar on FDA Records Keeping Requirements" http://biotechbistro.com/forum/topic/new-webinar-on-fda-records-keeping-requirements#post-7 Wed, 04 Feb 2009 10:47:51 +0000 javellan 7@http://biotechbistro.com/forum/ Cerulean Associates LLC, announces its new executive teleconference and webinar to be held on Thursday, February 19th at 2pm ET, Prove FDA Compliance with Easy Records Management Techniques. Limited to just 24 attendees, the one-hour teleconference will feature a 45-minute presentation by FDA compliance and records management expert, John Avellanet, followed by a 15-minute Q&A session. You download a detailed agenda of the presentation (and register to attend) at <a href="http://www.ceruleanllc.com/webinar" rel="nofollow">http://www.ceruleanllc.com/webinar</a> Mr. Avellanet is a former C-level executive for a biotech and medical device Fortune 50 subsidiary, who designed, built and ran his company's records management program. In 2006, Mr. Avellanet founded the regulatory intelligence and lean compliance program for executives and business owners, SmarterCompliance™. He is the author of more than 30 articles on lean compliance and FDA quality systems, a contributing author to the book Best Practices in Biotechnology Business Development (Logos Press), the publisher of the SmarterCompliance™ newsletter, and a frequent speaker with FDA officials. He can be directly reached through his independent advisory firm, Cerulean Associates LLC, on the web at <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a>.