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Published Articles and Case Studies

Downloadable reprints of more than 40 of our published articles, case studies and book excerpts.

1.  Lean Compliance

2.  IT Compliance (Part 11 and Annex 11)

3.  Quality by Design

4.  IP Security / Trade Secret Theft Prevention

5.  Other topics - Forecast for FDA in 2009, Solving the FDA Crisis, and more

 

Note:  all article reprints are in PDF format and will require the free Adobe Acrobat reader or similar.

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Lean Compliance

Bucking the Regulatory Affairs and Quality Outsourcing Trends  A recent survey highlights problems relating to the oversight of suppliers and outsourced contractors; this article provides suggestions for regulatory affairs and quality management departments to help avoid the problems.  This article is based on the earlier analysis in Cerulean's newsletter and a Compliance Zen blog posting.  Published in Regulatory Affairs Journal.

Available in July

Are "Land Mines" Hiding in Your Supplier Records?  When FDA cites a firm for "no justified rationale," what does that actually mean?  When it comes to supplier management records - from selection, to qualification, through monitoring and oversight - your documents, emails and memos are full of easily misinterpreted statements and glaring omissions begging for an inspector to construct a negative view of your operations.  This article presents some steps to take based on an interview with a former FDA prosecutor in Cerulean's newsletter.  Published in BioProcess International.

Available in July

Bottom Line Compliance for Biotechnology:  Six Secrets  Biotechnology executives frequently short-shrift one of the key indicators of return on investment when negotiating pharmaceutical partnerships, support or licensing:  a compliance and quality system.  Given the increasingly tight financial markets biotechnology executives must operate within, can a good quality system be established for less than the cost of an average car?  Originally published in the Journal of Commercial Biotechnology.

Download PDF  ($17 USD)

How to Meet Compliance and Records Requirements of the US FDA  Lays out an eleven-step strategy on how to implement effective document and records control to avoid falling afoul of the US Food and Drug Administration.  Includes specific SOP suggestions and recommendations to consider for your quality system.  This is a high-level summary of the program detailed in Cerulean's recorded seminar, FDA Records Retention and Requirements.  Published in the Regulatory Affairs Journal.

Download PDF  FREE

Want a Good Outsourcing Partnership?  Know How to Ruin One First  Case study of how a company bankrupted itself by poorly selecting and then managing its critical outsourced providers:  a development partner, contract manufacturer and then contract research organization.  Drawn from personal experiences years after the events took place, the article reviews six key lessons to avoid ruining your own company.  Originally published in BioProcess International.

Download PDF  FREE

Lean Outsourcing  Outsourcing in the biopharmaceutical and medical device industries continues to grow.  For executives grappling with how to get the biggest bang for their money, Cerulean's managing director provides five of the key insights he's provided to his clients over the years as part of his Lean Compliance strategy.  From the Contract Pharma magazine.

Download PDF FREE

Six Pitfalls to Avoid in Supplier Management  Managing suppliers is fraught with challenges.  Rare is the executive who has not made a mistake.  In this article, Cerulean's managing director, John Avellanet, looks at some of the most common mistakes - most of which he's personally made - and offers lessons learned on how to avoid making your own mistakes. Adapted from an article published in Cerulean's SmarterCompliance™ and the Biotech Blog.

Download PDF  FREE

Improving Compliance in an Economic Slowdown  Given the world-wide economic slowdown and attendant cost-cutting measures, how are companies to demonstrate - much less achieve - continual improvement for the quality and compliance programs?  The article discusses several tactics from Cerulean's Lean Compliance strategy; published in SmarterCompliance™.

Download PDF  FREE

Export Compliance for Life Sciences  U.S.-based pharmaceutical, biotechnology and medical device companies that work with offshore partners, ship equipment out of the U.S. or that re-export combination products with internal technology need to have a defined and well-tended export compliance program covering both tangibles and intangibles.  This article highlights eight steps to building a good export compliance program.  From the Journal of Commercial Biotechnology.

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Getting the Results You Expect from Consultants  Based on our managing director's experience as a biopharmaceutical executive, and honed with the help of CEO clients, this article presents seven straightforward steps to take to find and qualify the right consultant or professional service for you.  From BioPharm International.

Download PDF  FREE

Shared Risk:  A Regulatory Compliance Strategy  For regulators, biopharmaceutical and medical device risk seems so straightforward.  For pharmaceutical, biotechnology and medical device executives, however, risk is hardly clear-cut, particularly when global supply chains and vendors are involved.  This article expands upon a radio interview given by Cerulean's managing director in 2007 that charted a pathway to sharing the burdens of compliance with suppliers.  From BioProcess International.

Download PDF FREE

Lean Compliance for Midsized Companies  Turf battles, redundancies, and inefficiencies in handling compliance efforts cost companies millions each year.  The five themes of lean compliance - simplicity, rapid prototyping, agile risk, grow knowledge, and proof - are reviewed.  From the Journal of GXP Compliance.

Download PDF FREE

When Business Grows, Consider Renting a CIO  Reviews a growing trend among small and mid-sized businesses to hire interim or virtual Chief Information Officers instead of full-time executives.  Published in  TechJournal South.

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Cost-Effective IT Outsourcing  Presents three proven tactics to identify and implement an information technology (IT/ICT) outsourcing arrangement that will improve a company's bottom line.  Includes typical mistakes (and warning signs) to avoid.  From the Journal of IT Financial Management.

Download PDF  FREE

SMB Computer Validation:  Four Ways to Do More For Less  Small to mid-sized businesses and start-ups have it tough when it comes to regulatory compliance.  This "how-to" article presents four real-world tactics and examples to improve your compliance and achieve computer validation without busting your budget or working overtime.  From the Journal of Validation Technology.

Download PDF FREE

Positive Enforcement:  Seven Principles  Learn how to end compliance struggles without bringing in your HR department.  This article presents an overview of Cerulean's innovative Positive Enforcement strategy, with seven practical steps you can take today.  Published in Regulatory Affairs Focus.

Download PDF FREE

Empowered Compliance:  A Strategy to Support Your Company's Bottom Line One-in-five CEO's and other top executives are rated as too risk averse due to compliance worries to effectively compete in a global marketplace. This will give you the ability to impact your company's financial results with a sustainable competitive advantage. Supporting tactics and real-world examples for each of the five phases of the strategy allow immediate and practical usage.  From the Journal of Projects & Profits.

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IT Compliance (FDA 21 CFR Part 11 and EMEA Annex 11)

FDA 21 CFR Part 11 Revisited  Adapted from several SmarterCompliance™ newsletter articles plus recommendations from to members of the SmarterCompliance Toolkit program, this article discusses the role of record integrity in the revised 21 CFR Part 11.  Learn three key differences between the old and the newer Part 11, along with six recommendations to get a head-start on your competition.  Published in BioProcess International.

Download PDF  ($17 USD)

Getting Ready for the Revised Part 11  Discusses a proactive strategy of getting ready for the FDA's imminent release of the revised 21 CFR Part 11.  Uses a budget limit of $2,500 (USD) to put in place a strategy that can be implemented in 30 days or less.

Download PDF  FREE

Improving IT Compliance Return on Investment  Only 25% of the money spent on information technology goes toward new project and improvements; 75% of your IT/ICT budget just keeps the lights on.  As a result, few life sciences executives see IT/ICT as anything more than an expensive cost center.  In a tight economy, IT/ICT needs to improve its image.  This article lays out three things that IT/ICT can do to improve FDA quality systems compliance that don't cost a dime.

Download PDF  FREE

Virtualization: Taking Advantage of the New Part 11 to Save Money  GxP Lifeline interviewed Cerulean's Managing Director, John Avellanet, on the revised FDA 21 CFR Part 11, record integrity, and computer virtualization.  The interview discusses how companies can take advantage of where the agency is heading with Part 11 and the new technologies available.  Published in GxP Lifeline, March 2009.

Read the Interview  FREE

Virtualization and Validation  Argues that pharmaceutical, biotechnology and medical device companies would do well to look at the new technology capabilities of virtualization, especially when it comes to outsourcing IT / ICT functions and systems.  Lays out four steps to take to ensure compliance with current FDA and EMEA expectations around electronic record integrity and computer validation.  Readers can learn enough to put together their own business case for why virtualization makes sense in their company, how much money to expect to save, and how to tackle Part 11 concerns along the way.

Download PDF ($17 USD)

Part 11 Compliance and Quality by Design  Provides case studies with a strategy for implementing Quality by Design combined with aspects of 21 CFR Part 11 (electronic records) to improve a pharmaceutical, biotechnology or medical device company's new product pipeline, speed time to market and increase compliance and business flexibility.  Published in Pharmaceutical Manufacturing.

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Data Integrity Interview with John Avellanet  Following the filing of the data management lawsuit against Novartis, Pharmaceutical Manufacturing interviewed Mr. Avellanet about two of the allegations brought up in the legal compliant.  The interview discusses the issues brought up in the lawsuit in the context of other pharmaceutical, biotechnology and medical device companies.

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How to Prepare for an Inspection of Information Integrity  Last year, 95% of all regulatory enforcement focused on one topic:  the integrity - or lack thereof - of a company's information.  This article presents four steps to prepare for an inspection of your company's information integrity.  From SmarterCompliance™ and republished in Pharmaceutical Manufacturing.

Download PDF  FREE

Why CIOs Should Commoditize IT  This case study reviews the development efforts of a medical device company and the role its information technology organization played to speed both product innovation and time to market.  Published in BIO-IT World.

Download PDF  FREE

SMB Computer Validation:  Four Ways to Do More For Less  Small to mid-sized businesses and start-ups have it tough when it comes to regulatory compliance.  This "how-to" article presents four real-world tactics and examples to improve your compliance and achieve computer validation without busting your budget or working overtime.  From the Journal of Validation Technology.

Download PDF FREE

Six Rules for Great IT Project Success Between cost overruns, project delays, unfulfilled expectations and quality control issues, less than 30% of IT projects are successful. This is unfortunate because - conducted and delivered well - projects are one of the most powerful ways IT contributes to a company's bottom-line. Use these six rules to get your project back on track today.  From The Independent and the Journal of Projects & Profits.

Download PDF  FREE

The Rule of Salt: 100 Days to Increased Innovation through IT & Compliance Innovation is the key to competitiveness. Yet in 2005, 6 out of 10 companies admitted being unable to produce a single innovation that added to their financial results. At the same time, 73% of CEOs today don't believe they are getting their money's worth from their company's compliance and IT security and controls efforts. This article provides six steps you can take over 100 days or less to increase your innovation without compromising compliance or IT security.  Published by Ziff-Davis.

Download PDF  FREE

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Quality by Design

Speeding Time to Market with a Preclinical Stage Gate  One of the 120 strategies in the book Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine is the use of stage gate reviews.  This article explains in detail how to set up and run a cross-functional, preclinical stage gate review session.  Published in the European Biopharmaceutical Review.

Available in July (owners of the book can have today)

Back to School: Six Ways Universities can Aid Quality by Design Efforts  Excerpted from the four-part series on Quality by Design and personalized medicine published in the SmarterCompliance newsletter, this article lays out six tactics you can use to encourage Quality by Design in preclinical collaborations with universities.  Published in Pharmaceutical Manufacturing.

Read the Article Online  FREE

Can Compliance Help Marketing & Business Development?  In many FDA-regulated companies, the marketing and business development departments have a quietly antagonistic relationship with their quality and regulatory affairs colleagues.  This case study looks at how to turn compliance from the millstone around marketing's neck to the whetstone that helps hone a sharper competitive edge.  From the Journal of Commercial Biotechnology.

Download PDF  FREE

ICH Annex to Q8:  Quality by Design in Product Development The International Conference on Harmonization (ICH) has published its draft "Annex to Q8 on Pharmaceutical Development."  The draft document details the expectations of Quality by Design in the preclinical product development arena.  This analysis reviews your options to adapt the annex Q8-R to your environment.  From SmarterCompliance™.

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Quality by Design:  Defining Your Preclinical Package  Presents a real-world strategy for biopharmaceutical companies that need to develop a faster, less expensive, easier preclinical package for a new product.  The article is based on published FDA insights, discussions with FDA officials and other scientific experts, plus recent client experiences.  Published in European Biopharmaceutical Review.

Download PDF  FREE

Applying Quality by Design in Preclinical:  An Analysis The FDA's Quality by Design initiative presents a difficult decision to executives:  expand your manufacturing-based compliance programs into your product development environs or adopt a more innovative, less process-driven strategy known as "lean design."  This analysis discusses tactics to avoid overly prescriptive controls.  From SmarterCompliance™.

Download PDF  FREE

Part 11 Compliance and Quality by Design  Provides case studies with a strategy for implementing Quality by Design combined with aspects of 21 CFR Part 11 (electronic records) to improve a pharmaceutical, biotechnology or medical device company's new product pipeline, speed time to market and increase compliance and business flexibility.  Published in Pharmaceutical Manufacturing.

Download PDF  FREE

Elucidation:  Lessons from the Auto Industry  The FDA's Quality by Design (QbD) initiative is set to change how biopharmaceutical, biotechnology, pharmaceutical and medical device firms design, develop and test new products.  This article offers a strategy to leverage the lessons learned by Toyota back in the 1970s when implementing "lean design."  From BioProcess International.

Download PDF  FREE

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IP Security / Trade Secret Theft Prevention

Record Integrity and Licensing Your Intellectual Property  A must-have for any biotech or device executive hoping to strike a pharma deal, the article reviews the growing trend of pharmaceutical companies to scrutinize a biotech's records and scientific data.  The more a biotech company can meet or exceed pharma expectations, the better the biotech's bargaining position.  This article provides a step-by-step look at what a pharma due diligence team will examine versus an FDA auditor.

Download PDF  FREE

Saving Your Intellectual Property from Theft Patents, trade secret labels and confidentiality agreements are only so many words on a piece of paper to the scientist, engineer, support technician or executive intent on deception and theft.  In a global economy, your employees and contractors can make quick cash selling your proprietary information with the click of an email.  What are you doing to protect yourself and your investors?  Adapted from an article in SmarterCompliance™.

Download PDF  FREE

Intellectual Property Protection and Joint Development Agreements  Joint Development Agreements (JDA) can protect outsourced IP. This article lays out the three critical components of a functional, enforceable JDA. Adapted from an article published last year in Cerulean's executive newsletter and Mr. Avellanet's chapter on preventing intellectual property theft in the book Best Practices in Biotechnology Business Development.  Published in the Contract Pharma magazine.

Download PDF FREE

Protecting Intellectual Property & Compliance during Development Collaborations  New product development collaborations in the biopharmaceutical industry are a dual-edged sword, fostering innovation and speeding time to market while risking intellectual property loss and compromising regulatory compliance.  Use the six simple tactics in this strategy article to increase your intellectual property protection and improve your compliance capacity.

Download PDF (FREE)

How to Protect Your Records by Really Trying We rely upon records to document deliberations and detail decisions.  But records are also the means by which company executives are convicted or exonerated.  And when it comes to trade secret ownership, records are the proof upon which the courts rely.  To prevent financial loss, you must protect this proof.  Published in Cerulean's SmarterCompliance™.

Download PDF  FREE

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Other Topics

Solving the FDA Crisis  President Obama's reaction at the weak supervision by the FDA should not have been one of surprise.  As we (and many others) have noted for years, the agency is plagued by chronic understaffing and other woes while its sphere of oversight has continued to expand in an increasingly globalized economy.  This article presents three recommendations for Congress and the FDA to undertake to have any real prospect of lasting change.

Download PDF  FREE

FDA Forecast for 2009  During the course of every year, executive members of the SmarterCompliance Toolkit program receive detailed analyses of upcoming FDA changes that will impact their businesses.  For pharmaceutical executives struggling with long product development lifecycles, this type of compliance intelligence is a powerful help in planning strategy, allocating resources and defining priorities.  This article summarizes some of the key takeaways members felt were the most important over the past year.

Download PDF  ($17 USD)

Putting the Biotech Puzzle Pieces Together  Presents a community coalition-based strategy for states interested in growing their biotechnology economies can adopt; draws upon lessons learned from Massachusetts, North Carolina and Florida.  Published in the Virginia Business Magazine.

Download PDF  FREE

Adapting to Global Competition  Trying to lure top employees, investors and low-risk startups has become increasingly difficult; particularly as each region pushes for biotechnology growth as the panacea for economic development.  This article provides three brief strategies - with examples - to consider to help you adapt and flourish in a "flat world."  Adapted from an article in SmarterCompliance™ and published in The Independent.

Download PDF  FREE

Simple Computer Maintenance for Small Businesses & Nonprofits The average computer lasts approximately 3-4 years before it's replaced. For small businesses and nonprofits, that cost could be better allocated toward improving their bottom-line than speeding word processing. Use the five plain English recommendations in this article to increase your computer's usable life and focus your monies on improving your livelihood. Published on IT Hot News, the website for small business technology advice, and then reprinted in The Independent.

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Five Steps to Extend Your Computer's Life Written specifically for nonprofits, this article is a revised version of the "Simple Computer Maintenance for Small Businesses & Nonprofits" article (above), and incorporates elements from Cerulean's workshop for nonprofits on cost-effective IT strategies.  Originally published on TechSoup, the non-profit technology site.

Download PDF  FREE

15 Seconds on the Web: Ten Writing Tips to Improve Sales The average visitor to your website makes a decision to buy or move on in 15 seconds or less. Based on research from behavioral scientists, web consultants and academia, this article provides ten practical techniques that you can apply today to make the most of those 15 seconds and improve your sales.  Published on SiteReference; one of the 5 best-rated articles on the web in 2006.

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Hardball Learning Do you have the backbone to engage your audience in a conversation? Long after the presentation, hardball presenters and their material remain memorable. Use these six simple strategies to shift your position from podium-presenter to focused facilitator.  Originally published on Ezine Articles.

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