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Helpful Links

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Compliance
FDAnews
One of the top information and news providers on U.S. Food and Drug Administration regulations and their impact. They have multiple newsletters depending upon your specific industry focus.
Food & Drug Law Institute
The most respected educational resource for the discussion of laws, regulatory impacts and public policy for communities under the jurisdiction of the FDA (as well as the USDA, the FTC and several other agencies involved in biologics, pharmaceuticals and food). The non-profit FDLI has been in existence since 1949.
Sarbanes-Oxley Compliance Journal
A world-class journal focused on all aspects of Sarbanes-Oxley compliance.
21CFRpart11.com
A good resource on the FDA's Part 11 rule. It is maintained and supported by Waters Laboratory Informatics company.
Institute of Validation Technology
The publisher of the Journal of Validation Technology and the Journal of GXP Compliance, the IVT hosts numerous conferences for professionals in organizations regulated by the FDA.
Parenteral Drug Association
Founded in 1946, this non-profit association promotes practical scientific and compliance information for the pharmaceutical and biotech industries, as well as for regulatory agencies. The PDA provides excellent certified supplier audits that can significantly trim your compliance costs.
Lab Compliance
Run by Dr. Ludwig Huber, one of the top laboratory FDA-compliance experts in the world, the site focuses on news and solutions for laboratories.
International Conference on Harmonization (ICH)
This project is in the process of aligning pharmaceutical regulations across Europe, the United States and Japan.
Global Harmonization Task Force (GHTF)
This project is in the process of aligning medical device regulations across Europe, the United States and Japan.
International Organization for Standardization (ISO)
Many of the ISO standards form the backbone of regulations world-wide. Generally, if you can meet or exceed ISO standards, you can meet or exceed regulatory compliance.
Good Automated Manufacturing Processes (GAMP) Publications
Founded in 1991, and then partnered with the International Society for Pharmaceutical Engineering in 1994, the GAMP forum is one of the most recognized international authorities on computer system validation and FDA compliance.
F-D-C Reports
Now owned by Elsevier, authors of the The Pink Sheet, The Gold Sheet, The Gray Sheet, The Silver Sheet and other top business publications for executives and analysts.
Food Navigator USA
A news service organization dedicated to breaking news on food and beverage regulations.
European Commission
Split into three distinct directives and regulation areas:  pharmaceuticals, medical devices and biotechnology.
GMP Institute
Founded in 1977, the nonprofit international organization is dedicated to providing training on the FDA's Good Manufacturing Practices worldwide.
FDA Law Blog
Provided by several of the top lawyers in the country that specialize in FDA law, the blog covers legal trends that impact FDA compliance (such as DEA advisories, export compliance, and so on).  It is updated irregularly.
 
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Pharmaceutical, Biotechnology and Medical Device Information
Biotech Blog
The BiotechBlog is syndicated to Reuters, Biospace and other media outlets.  Managed by Dr. Yali Friedman, the editor of the Journal of Commercial Biotechnology and a guest lecturer at Johns Hopkins University.
In the Pipeline Blog
Written by Dr. Derek Lowe, a former pharmaceutical drug discoverer, the blog focuses on issues relevant to scientists, academics and economists.
PharmWeb
Launched in 1994, PharmWeb is a pharmaceutical information portal combing over 15,000 sites and 100 moderated discussion forums and blogs by pharmaceutical and healthcare professionals.
 
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New Product Development & Innovation
Yet2.com
Founded in 1999, this global site works to bring buyers and sellers of technologies together to help organizations leverage intellectual properties collecting dust on shelves around the world.
Product Development & Management Association
The global association of product development and management professionals full of resources, tips and lessons learned, and best practices.
Management Roundtable
The top resource on the web for information and cutting-edge practices on innovation, new product development and technology road-mapping.
Innovation Tools
Established in 2002, this website is focused on providing resources and links for innovation in business, from mind-mapping techniques to brainstorming software tools. Maintained by Chuck Frey, a veteran guru on creativity in enterprises.
Wiki Law
You might not think of lawyers when it comes to innovation, but if you plan on patenting anything, intellectual property law comes to mind.  Wiki Law is a comprehensive site of legal news, forums, articles, "how to" Q&A and FAQs, a dictionary of common legal terms, and so on.  It's intellectual property section has directories and links to a number of useful sites.
 
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Drug & Device Safety
DrugWatch
Features a comprehensive list of drugs and medications that are currently on the market, or were previously available worldwide. You can also get updated information on drug recalls, medication approvals, and current developments in the medical field.
Drug Recall
A Drug Recall is committed to providing the latest news and information about defective and harmful drugs. They offer breaking news stories, tips for consumer safety, information on alternatives, and more.
 
 
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Information Privacy & Security
Electronic Privacy Information Center
One of the most respected resources for information on electronic privacy in the world.
Privacy International
Formed Formed in 1990, a non-profit, human-rights organization dedicated to the protection of personal privacy.
OnGuard Online
A joint resource from the U.S. government and the technology industry on protecting your computer, your private information and reducing the risk of identity theft.
Privacy Journal
Since 1974, this international newsletter has dedicated itself to supporting the right for privacy. It is full of practical tips, news updates, and links to other organizations in which you can become involved.
Privacy Rights Clearinghouse
FoundedFounded in 1992, this is a non-profit consumer privacy organization focused on supporting privacy rights and securing individual access to their own records and information.
GetNetWise
This non-profit organization is dedicated to presenting easily understood information on electronic privacy, wireless security, safe web-surfing, stopping spam and keeping your children safe on-line.
Index Security
This company makes an excellent biometric-secured USB flash drive. We've used one for several years now with no problems. While they also have related products for large enterprises to facilitate wide-scale biometric adoption, we particularly like the personal security the USB drive provides.
 
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Internet Security & Safety
McAfee SiteAdvisor
A downloadable tool for Internet Explorer and Firefox that test sites to minimize your exposure to adware, spyware, excessive pop-ups, etc. while you browse the web.
CAUCE (Coalition Against Unsolicited Commercial Email)
An all volunteer organization of citizens, nonprofits and organizations advocating for legislative solutions to the problem of spam.
Anti-Spam Bots!
Another non-profit, volunteer organization that has put up a webpage designed to trick spammers into harvesting thousands of junk, fake emails (including their own!).  Nothing like fighting fire with fire....
 
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Technology Research
Common Criteria
First available in 1996, this is a joint venture between Europe, Canada and the United States to align and evaluate IT security; version 2.0 of the Common Criteria was adopted by ISO. The Common Criteria's Evaluated Assurance Level (EAL) rating of security products is the first place to start when researching electronic security products; the lower the rating, the higher the risk.
BetaNews
One of the top sites with inside scoop on beta software releases, technology goings-on, etc.
AppleInsider
A similar site to BetaNews, but focused only on Apple and Mac-related products.
Toms Hardware
Begun in 1996 to help the build-your-own PC market, the site is now the pre-eminent location on the web for independent computer hardware information and evaluation for the enterprise and the home.
CNET Reviews
A fairly comprehensive review site of technology from cell phones to web hosting services.
 
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Directories of Experts
Yearbook of Experts
Since 1984, this is the site LexisNexis® pulls from as do many other news and media sources for expert resources.
ConsultantsRegistrar.com
A directory of consultants searchable by specialty focus, region, expert witness services and even previous clients (for those that disclose client names).  Go directly to Cerulean's profile.
Institute of Management Consultants
Founded in 1968, the IMC is a professional society for management consultants and provides profiles of its members.
Society of Professional Consultants
Established in 1986, the non-profit organization maintains a free referral and profile service if you need a professional speaker, trainer or consultant; focused on the Northeast region of the United States.
 
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For Non-Profits & Educational Institutes
TechSoup
The most respected site for help with technology for non-profit organizations worldwide, including providing provider profiles, helpful blog links, and "how to" articles.
N-TEN
The Nonprofit Technology Enterprise Network connects a broad group of individuals, companies, non-profits, and vendors who desire to help non-profit organizations use technology more effectively. They have a number of excellent articles, links, and forums.
Network for Good
Founded in 2001, this not-for-profit e-philanthropy site is maintained by Cisco, AOL, Yahoo! and other companies to encourage use of the internet for fundraising and volunteerism.
Nonprofit Good Practice Guide
From the Dorothy A. Johnson Center for Philanthropy and Nonprofit Leadership, this site has nearly 7,000 resources, website profiles, and terms to help manage a nonprofit organization.
Innovation Network
A non-profit organization that shares planning and evaluation tools, advice, training and consulting for both non-profit organizations and their funders.
Summit Collaborative
A networked organization that provides research, program development and management support for non-profit and foundations.
Benton Foundation
Originally set up in 1948, and then refocused in 1981, the foundation provides an extensive library of advice, toolkits, strategies, and technology ideas for nonprofits and educational institutions. Even with the dated reports, the core concepts are still relevant and actionable.
StepByStepFundraising
An index site of fundraising ideas, links, suggestions for nonprofit organizations and educational institutions. Some of the ideas are traditional, some will be more appropriate than others for your organizational/mission, and some of the ideas are truly inspired.
Fundraisers
A marketing-focused, community website for getting your message out there, with ideas, resources, and organizations to help fund your mission.
 
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Miscellaneous
Pharmaceutical-LifeSciences Association List
This is a complete listing of all pharmaceutical, biotech and healthcare industry and professional associations world-wide.
 
 
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