http://biotechbistro.com/forum/tags/quality-systems The Business of Biotechnology en-US Wed, 08 Sep 2010 07:33:45 +0000 bbpress 1.0-alpha-4 q http://biotechbistro.com/forum/search.php 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/ <p>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.</p> <p>Compliance Zen is through TypePad at: <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a> </p> <p>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).</p> <p>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> </p> http://biotechbistro.com/forum/topic/fda-regulatory-agenda-for-2009-matches-forecast-by-cerulean#post-11 Sat, 28 Feb 2009 15:29:53 +0000 javellan 11@http://biotechbistro.com/forum/ <p>Documents released by the US Food and Drug Administration (FDA) last week laid out a schedule of regulatory guidance and agency expectations largely mirroring those forecast in December's SmarterCompliance newsletter.</p> <p>Cerulean Associates LLC publishes the monthly SmarterCompliance newsletter, subscribed to by pharmaceutical, device and biotech executives around the world, and issues an annual forecast for the upcoming year between November and December.</p> <p>"Last year," said Managing Director, John Avellanet, "our forecast gave over 40 recommendations for 2009, most of them just summaries of our more in-depth analyses we published throughout the year in the newsletter. We’re really starting to see subscriptions take off as executives realize the business implications of getting a good 12 to 18 month lead on their competitors and the inspectors."</p> <p>The December SmarterCompliance forecast that the FDA would release a revised version of 21 CFR Part 11, a Good Importer Guidance, Process Validation advice, and more guidance documents supporting the implementation of various aspects of Quality by Design throughout the lifecycle – from preclinical to postmarket – of drugs and biologics. The FDA's agenda as published by the Center for Drug Evaluation Research (CDER) specifies just those items. To help executives who have not had a chance to evaluate SmarterCompliance, Cerulean has made the first half of its December issue available for free download (visit <a href="http://www.ceruleanllc.com/newsletter/" rel="nofollow">http://www.ceruleanllc.com/newsletter/</a>).</p> <p>"Currently," said Mr. Avellanet, "we're turning our attention to the new drug and biologic pipeline implications of personalized medicines; so far we've published dozens of recommendations for our readers along with approximate timelines of marketplace adoption and regulatory rulings."</p> <p>"Let's not kid ourselves," cautioned Mr. Avellanet. "Our February 2008 prediction that some sort of regulatory pathway for follow-on biologics would be in place by the end of this year [2009] may or may not come to pass. The initial budget from the new administration supports such a move, but a whole lot of maneuvering has to go on before a generic biologics pathway exists."</p> <p>Cerulean's SmarterCompliance newsletter 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.</p> <p>Journalists who would like a complimentary subscription to Cerulean's SmarterCompliance newsletter can contact Mr. Avellanet directly through the Cerulean website.</p> <p>Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and 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>.</p> <p>### </p> http://biotechbistro.com/forum/topic/two-fda-quality-systems-compliance-resources-published#post-9 Fri, 20 Feb 2009 16:11:11 +0000 javellan 9@http://biotechbistro.com/forum/ <p>Two new FDA quality systems compliance resources – <strong>Bulletproof Yourself against FDA Enforcement</strong> and <strong>FDA Quality Systems Records Requirements for GLPs, GCPs, GMPs</strong> – have been published by the SmarterCompliance™ newsletter and Cerulean Associates LLC.</p> <p>Both publications combine recorded executive teleseminars with resource kits of checklists, templates, example FDA warning letters, and other reference material designed to ease implementation of various recommendations and expert advice.</p> <p><strong>Bulletproof Yourself against FDA Enforcement</strong> builds on Cerulean’s in-depth industry report from last year, FDA Enforcement Trends 2008-2009, and adds a review of the top 10 agency inspection priorities for domestic US and international sites, four detailed self-assessment checklists, a step-by-step strategy for ensuring positive inspection outcomes, three article reprints, and an hour-long audio-visual analysis of the FDA priorities for 2009 along with recommendations to stay off the FDA radar screen for the next 12-18 months. Also included is a complimentary copy of the industry report, FDA Enforcement Trends 2008-2009.</p> <p><strong>FDA Quality Systems Records Requirements</strong> includes a 9-page matrix of FDA records and documentation requirements for firms during GLPs, GCPs, and GMPs, an 11-step strategy overview guide, several self-assessment checklists, a policy framework template, multiple article reprints, and other reference materials. Also included is an hour-length audio-visual recording of last week’s executive teleconference with questions and answers from the audience.</p> <p>Both resource kit publications are available – either in download format or CD and hard copy – through the Cerulean website at <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a>.</p> <p>Cerulean’s next online seminar for executives, <strong>Frugal FDA Compliance: Getting More Done with Less</strong>, is scheduled for Tuesday, March 24. Want to attend? Visit <a href="http://www.ceruleanllc.com/webinar" rel="nofollow">http://www.ceruleanllc.com/webinar</a> to learn more and register.</p> <p>Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and 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>.</p> <p>### </p>