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Bio-IT World April 15, 2003 Barbara Depompa Reimers	Easing the Pain of Part 11 Costs for complying with FDA electronic records regulations will cost millions of dollars per company by 2006. Risk-based processes can lighten the load.
Bio-IT World April 15, 2003 Heller & Philbin	Part 11: The FDA's New View The FDA now has a softer perspective on enforcement, but companies will still have to watch their step.
Bio-IT World April 15, 2003 Janet Woodcock	FDA Director Explains the Changes The head of the Center for Drug Evaluation and Research discusses why the FDA is now kinder and gentler about Part 11 compliance.
Chemistry World October 23, 2012 Clive Thompson	Analytical method validation Handbook of Analytical Validation by Michael Swartz and Ira Krull should be an integral part of drug and biotechnology laboratories for both training staff and for comprehensive advice on how to deal with a very wide range of specific issues relating to AMV.
OCC Bulletin May 30, 2000	Risk Modeling This bulletin provides guidance to help financial institutions mitigate potential risks arising from reliance on computer-based financial models that are improperly validated or tested...
Bio-IT World January 12, 2004 Steve Lefar	Systematize Your Regulatory Info! Want better protection against regulation breaches? Build a system that engenders 'grassroots' compliance.
Food Processing February 2011 David Joy	7 Things You Should Know About The New Food Safety Law Considered a win for consumers, the new law will have varying effects on food & beverage processors.
Bio-IT World April 16, 2004 Salvatore Salamone	Documents Under New Management Life science companies are turning to document or content management systems with workflow features to run more efficient organizations.
Insurance & Technology August 12, 2005 Peggy Bresnick Kendler	The Compliance Challenge Industry experts offer opinions on what the biggest challenges carriers currently face in terms of regulatory compliance.
Pharmaceutical Executive June 1, 2011 Zhang & Dubman	To Genzyme, Quality Data Depends on Quality Governance The payoff is superior performance in key areas such as clinical trials
Food Engineering May 1, 2005 John Blanchard	Beyond the Bioterrorism Act What you need to know about the final rule and additional initiatives to meet the intent of the Bioterrorism Act -- particularly Section 306, which relates directly to those who manufacture, process, pack, transport, distribute, receive, hold, or import food products.
Chemistry World October 23, 2013 Sarah Houlton	Pharma manufacturing woes dog industry Many problems arise from quality control failures, according to Nicholson Price from Harvard Law School's Petrie-Flom center for health law policy, biotechnology and bioethics, this is not the only problem -- regulatory constraints can prevent process improvements being made.
Bio-IT World September 16, 2004 Paul King	Growing Gains When it comes to information technology requirements, the biotech industry is unlike any other. A key enabler of efficient and effective growth is the adoption of IT strategies specific to each of four key stages.
Bio-IT World February 11, 2005 Judy Hanover	Leveraging IT to Achieve Compliance Budgeting and measuring the success of compliance initiatives is a credibility issue for CIOs.
Bio-IT World May 2006 Chris Connor	Will SOX Crush Clinical Development? Just as clinical operations and data management personnel were feeling as though they had tamed their compliance beasts of burden, many life science companies have noticed another elephant in the living room, and this one is wearing SOX.
Pharmaceutical Executive January 1, 2009 Jill Wechsler	FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order?
Pharmaceutical Executive January 1, 2013 Ben Comer	Compliance in the C-Suite Compliance officers have risen into pharmaceutical management's highest ranks, by choice in some organizations, and by government decree in others. Either way, their importance as a strategic partner can hardly be understated.
Food Processing February 2012 Eric Lindstrom	The FDA's Food Safety Outlook for 2012 The FDA will be consumed with implementing the Food Safety Modernization Act, with July as a particularly important month.
Food Processing March 2013 Eric Lindstrom	Do you know your HACCP from your HARPC? FDA's FSMA ruling requires food processors to create risk-based preventive control plans.
CIO March 15, 2006 Allan Holmes	Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market.
Food Engineering February 1, 2008 Richard F. Stier	Are Regulators Endangering Our Food Supply? The FDA comes under fire as reports of mismanagement come to light.
Food Engineering January 1, 2007 Wayne Labs	Implementing Best Practices Applying a best practices strategy in parallel with an automation strategy can enhance your competitive edge. But one size doesn't fit all.
CFO April 1, 2007 John Edwards	A Sense of Validation Hosted applications -- also known as software as a service (SaaS) -- are uniquely suited for businesses in highly regulated sectors because many Web-hosted applications and processes have already been vetted by regulators.
Pharmaceutical Executive February 1, 2011 Jill Wechsler	Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency
Chemistry World May 23, 2012 Andy Extance	Drug watchdogs mark out global territory The US Food and Drug Administration has published plans to ensure that American citizens continue to enjoy access to safe drugs, even as the regulatory pressures of globalization grow.
Pharmaceutical Executive December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
IndustryWeek October 19, 2011	FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies?
Pharmaceutical Executive January 1, 2006 Clinton & Wechsler	What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay?
Pharmaceutical Executive October 1, 2008 Chris Biddle	Stop the Bleeding Pharmaceutical manufacturers overpay pharmacy benefit managers millions of dollars each year in rebate overpayments. Here's how to stop the leakage.
Food Processing January 2013 Eric Lindstrom	Food Safety Regulatory Outlook for 2013 Similar to 2012, the FDA will continue to evolve and enact the Food Safety Modernization Act.
Investment Advisor February 2008 Papa & Marks	The New Paradigm Integrating operations and compliance.
Pharmaceutical Executive August 1, 2012 Jill Wechsler	Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act.
Pharmaceutical Executive February 1, 2012 Jennifer Ringler	Industry Trees are Falling, But is FDA Around to Hear? Experts weigh in on FDA's long-awaited social media guidelines.
Wall Street & Technology March 1, 2004	Getting Management on Board With Compliance Compliance and litigation readiness have blasted up the priority list of top management. Leading financial institutions have appointed general counsel into top management roles. Boards of directors are reviewing and approving technology solutions.
Bio-IT World March 17, 2004 Zachary Zimmerman	Testing Times for the FDA The FDA's pharmacogenomic guidance marks the beginning of a long process toward standardized tests.
Pharmaceutical Executive December 1, 2005 Jill Wechsler	Washington Report: Big Production Drug manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design, which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning.
Pharmaceutical Executive October 1, 2012 Jill Wechsler	Changes and Challenges at FDA New user fee programs precipitate major changes at an agency under constant and intense scrutiny.
Financial Planning September 1, 2006 Jane Worthington	Accounting for Compliance Instead of viewing compliance as a necessary evil, financial advisors should see it as a cost of doing business and learn how to quantify that cost.
PC Magazine June 22, 2005 Neil J. Rubenking	Genuine Microsoft Windows I got a call from one of my students who's in a panic because the Dell computer his son gave him came with what Microsoft said was a bootleg copy of Windows XP Professional. What should he do?
Pharmaceutical Executive June 1, 2012 Jill Wechsler	Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.
Pharmaceutical Executive June 1, 2009 Jill Wechsler	A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight.
Prepared Foods January 2008 Mark S. Hostetler	Regulations: That's the Plan The much-anticipated Food Protection Plan from the FDA integrates two plans that address safety for domestic and imported foods.
Bio-IT World September 2005 Mark D. Uehling	Murky Diary Entries The FDA is planning to clarify the degree to which existing patient diary technologies are (or are not) encroaching on data-management duties formally assigned to clinical investigators. That guidance is in the works, with no known timetable.
Pharmaceutical Executive January 1, 2012 Jill Wechsler	New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation.
Food Engineering May 1, 2005	7th Annual Essential Guide to Manufacturing Software: Think of 21 CFR as win-win The latest software performs double duty: helping food processors and transporters respond to FDA demands and helping to control inventory, energy costs and security.
Pharmaceutical Executive June 1, 2006 Jill Wechsler	Washington Report: Promises to Keep Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules.
Bio-IT World August 13, 2002 Mark D. Uehling	Clinical Trial Data Management: Tortured by Paper Reams of paper stuffed into boxes and shipped to the FDA by the truckload is hardly the best approach to drug approval. But what's the right way?
Pharmaceutical Executive January 1, 2011 Jill Wechsler	Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead.
Pharmaceutical Executive August 1, 2008 Jill Wechsler	Can Sentinel Save Drug Development? FDA's new sentinel system shows the pendulum swing toward safety won't swing back anytime soon.
Food Processing October 2008 Diane Toops	A Conversation with Food Safety Czar David W.K. Acheson A exclusive conversation with `food safety czar' David W.K. Acheson, FDA's Associate Commissioner for Foods.