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Published Articles & Case Studies

Downloadable reprints of our published articles, case studies& book excerpts

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Lean Compliance

Lean Compliance for Mid-Sized Companies

Turf battles, redundancies, and inefficiencies in FDA compliance efforts cost companies millions of dollars each year.  The five themes of lean regulatory compliance – simplicity, rapid prototyping, agile risk, grow knowledge, and retain the right proof – are reviewed with examples and steps to start on today.  Originally published in the Journal of GXP ComplianceGet the PDF

Rapid Deployment Tips to Prepare for an FDA Inspection Quickly

SOPs and training aside, what do you do when the FDA investigator suddenly knocks upon the door? How do you really prepare for an inspection when you have hours or just a few days? This article walks you through seven impactful steps to take in less than 24 hours. Originally published in the PDA Newsletter | Get the PDF

Bottom Line Compliance for Biotechnology:  Six Secrets

Startups and biotechnology executives frequently short-shrift one of the key indicators of return on investment when negotiating pharmaceutical partnerships or licensing:  the bottom line impact of FDA compliance.  Given the tight financial constraints many startups and biotech executives face, can an effective FDA-compliant quality system be established for less than the cost of an average car?  Originally published in the Journal of Commercial BiotechnologyDownload the PDF

Building Compliance for Personalized Medicine

Discusses the demographics working against the biopharmaceutical industry when it comes to ensuring compliance as new personalized medicines move through the development pipeline.  Provides four tactics executives need to start adopting to get their organizations ready for the next decade.  From BioProcess InternationalGet the PDF

Is Three-Batch Validation Obsolete?

Where is the new process validation guidance leading us? An analysis of the new process validation guidance document from FDA with suggestions for how to prove compliance to the inspector. Originally published in the SmarterCompliance newsletter, then adapted and published in Contract Pharma | Read the PDF

Report:  Ten Ways to Control Compliance Costs

Filled with facts, examples, case studies, and ten specific tactics to adopt today, this 29-page booklet is designed to help executives improve the cost-effectiveness of their regulatory compliance programs  |  Download the PDF

Positive Enforcement:  Seven Principles

Learn how to end compliance struggles across your organization without having to bring in the HR department or escalate to higher-ups.  This article presents seven practical steps from Cerulean’s lean FDA compliance strategies you can take today to ensure people comply.  Published in Regulatory Affairs FocusDownload the PDF

IT Compliance (Part 11 & Annex 11)

21 CFR 11 Enforcement: Where is the FDA Headed?

What is the driving intent behind FDA’s Part 11 special extended inspections?  What are inspectors looking for?  This article looks at the two high-risk areas that FDA investigators have been trained to scrutinize in order to decide if a firm should be subject to an extended 21 CFR 11 inspection. Published in Contract Pharma | Get the PDF

FDA 21 CFR Part 11 Revisited

This article discusses the role of record integrity in FDA’s scope revisions to 21 CFR Part 11.  Learn three critical differences between the old and the newer Part 11, along with with six practical recommendations to get a head-start on easier Part 11 compliance.  Published in BioProcess InternationalDownload the PDF

Getting Ready for the Revised Part 11

In 2009, FDA’s CDER published its list of upcoming coming guidance documents and regulations to be completed by year’s end; after long last, Part 11 was listed. And yet, December 2009 came and went, and the FDA postponed publication yet again. This article discusses what FDA expected to change in the revised, new 21 CFR Part 11. Published in Pharmaceutical Processing | Download the PDF

Is Software as a Service (SaaS) in Your Future?

How do you adopt and validate hosted software? This article provides the pros and cons of software as a service (SaaS) in the biopharmaceutical arena, and includes an candid discussion with a former SaaS supplier executive. Published in Pharmaceutical Processing | Get the PDF

SMB Computer Validation:  Four Ways to Do More With Less

Small to mid-sized businesses and startups have it tough when it comes to 21 CFR Part 11 compliance.  In short, there’s simply never enough resources to tackle it appropriately.  This article lays out four practical tactics and examples to simplify Part 11 compliance and achieve computer system validation without busting the budget.  Published in the Journal of Validation TechnologyGet the PDF

Improving IT Compliance Return on Investment

Less than 15% of pharmaceutical and biotechnology executives see IT departments as enabling business success, much less regulatory compliance. In a tight global economy, what does IT need to do in order to prove its worth when it comes to regulatory compliance and quality systems? This article lays out three things that IT can do that cost nothing.  Published in Pharmaceutical Processing | Download the PDF

Why CIOs Should Commoditize IT

This case study reviews the development efforts of a medical device company and the role its information technology (IT/ICT) group played to speed product innovation, cut costs, and ensure down-to-earth 21 CFR Part 11 compliance.  Originally published in BIO-IT WorldDownload the PDF

Quality by Design

Report:  Executive’s Guide to Quality by Design

This briefing highlights the history of the FDA’s quality by design initiative, then provides an overview of quality by design concepts from preclinical through postmarket surveillance.  With quick to grasp definitions and examples  |  Download the PDF

Speeding Time to Market with a Preclinical Stage Gate

Explains in detail how to set up and run a cross-functional, preclinical stage gate review session to ensure bulletproof clinical planning and faster time to market.  One of the 120 strategies and tactics from the book Get to Market Now! Originally published in the European Biopharmaceutical ReviewGet the PDF

Can Compliance Help Marketing & Business Development?

This case study looks at how to turn compliance from the millstone around marketing’s neck to the whetstone that hones a sharper competitive edge by improving venture funding and speeding time to market.  Based on Cerulean’s lean compliance consulting services.  Originally published in the Journal of Commercial BiotechnologyDownload the PDF

Quality by Design:  Defining Your Preclinical Package

Presents a practical strategy for biopharmaceutical companies that need to develop a quality by design, risk-based preclinical package for a new product to discuss clinical development plans with FDA and other regulatory health agencies.  Published in the European Biopharmaceutical ReviewGet the PDF

Workbook:  Is Quality by Design Right for My Organization…?

Filled with facts, questions to answer, plus an innovative starting blueprint of five tactics to speed time to market and reduce development costs.  This 36-page workbook is designed to help executives assess how appropriate quality by design is for their company  |  Download the PDF

Report:  FDA Quality by Design & Modern Quality Systems

Details many recommendations from FDA officials on quality by design and 21st century quality system expectations.  Topics include:  the current FDA approach to ensure ICH compliance, recommendations for annual management reviews and CAPAs, top 3 ways that inspectors are trained to assess whether management is following through on an intent to comply, how to apply risk-based decision-making throughout your organization, and more  |  Download the PDF

How Part 11 Impacts Quality by Design

Case study and strategy for implementing quality by design and automating components of quality by design such as process analytical technology under a 21 CFR Part 11 compliant approach.  Shows how this can speed time to market and increase business flexibility while maintaining current compliance requirements.  Originally published in Pharmaceutical ManufacturingDownload the PDF

Elucidation:  Lessons from the Automobile Industry

This brief article offers advice on how best to leverage lessons learned by car makers such as Toyota, Honda, BMW and others back in the 1970s when implementing “lean design” techniques.  Published in BioProcess InternationalGet the PDF

Intellectual Property Protection & Joint Development Agreements

A joint development agreements (JDA) can protect intellectual property developed in collaboration with outsourced suppliers and business partners if the JDA is constructed appropriately.  This article lays out three critical components of an effective, enforceable JDA in line with quality by design expectations.  Published originally in Contract PharmaDownload the PDF

Records Management & Retention

How to Meet Compliance and Records Requirements of the US FDA

Lays out an eleven-step strategy for how to implement effective document and records retention control to avoid fall afoul of cGMP, GLP, GCP and QSR regulations.  Published in the Regulatory Affairs JournalDownload the PDF

Are “Land Mines” Hiding in Your Supplier Records?

When FDA cites a firm for “no justified rationale,” what exactly does that mean?  When it comes to records you maintain on your suppliers – from selection to qualification through monitoring and oversight – your documents, emails, memos, and internal presentations are full of easily misconstrued statements and glaring omissions begging for an inspector to construct a negative view of your operations and decision-making intent.  This article presents some defensible documents activities to take based on an interview with a former FDA prosecutor.  Adapted from an article in Cerulean’s SmarterCompliance newsletter, and re-published in BioProcess InternationalGet the PDF

Record Integrity & Licensing Your Intellectual Property

A must-have article for any biotech or device executive hoping to strike a pharma deal, this article reviews the growing trend of pharmaceutical companies scrutinizing records and scientific data to find weaknesses.  The more a firm can meet or exceed pharma expectations, the better the bargaining position.  The article provides a step-by-step look at what a pharma due diligence team (such as in a mock FDA audit) will examine versus an FDA inspector.  Originally published in the Journal of Commercial BiotechnologyDownload the PDF

Protecting Trade Secrets & Records Compliance during Development Collaborations

New product development collaborations in the biopharmaceutical industry are a dual-edged sword:  they foster innovation and speed time to market while risking intellectual property loss and compromising regulatory compliance.  Use the six tactics in this article to protect your nascent intellectual property and improve your compliance capacity.  From the European Biopharmaceutical ReviewGet the PDF

Supplier Management, Oversight & Qualification

FDA Expectations for Parenteral Supplier Controls

Supplier management challenges are growing – from controlling the supply chain to auditing contract suppliers.  Does a recent internationally harmonized device guidance hold the key?  Published in Contract PharmaDownload the PDF

Bucking the Regulatory Affairs & Quality Outsourcing Trends

A recent survey highlights problems related to the oversight of suppliers and outsourced contractors; this article provides suggestions for regulatory affairs and quality management departments to help avoid the problems.  Published in Regulatory Affairs JournalGet the PDF

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, a contract manufacturer, and a contract research organization.  Drawn from personal experiences years after the events took place, the article reveals six crucial lessons to avoid ruining your own company.  Originally published in BioProcess InternationalDownload the PDF

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, this article provides five key insights from a lean compliance strategy.  Originally published in Contract PharmaGet the PDF

Shared Risk:  A Regulatory Compliance Strategy for Supplier Oversight

Risk is hardly straightforward when global supply chains and multi-tier suppliers are involved.  This article expands upon a radio interview with Cerulean’s John Avellanet that charted a lean compliance pathway to sharing the burden of compliance with suppliers.  Published in BioProcess InternationalDownload the PDF

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 and lower risks; fully adaptable to other functional outsourcing activities.  Includes typical mistakes and their warning signs.  Published in the Journal of IT Financial ManagementGet the PDF

Get to Market Now! Book Excerpts

Introduction & Chapter One

Lays out why the biopharma industry needs new ways of thinking about regulatory compliance, quality systems, and new medicinal product development that reflect the changing landscape of the 21st century.  Gives examples and insights from industry executives and FDA officials.  Also includes detailed table of contents, list of illustrations, tables and figures, and information on where to buy.  See more at the book’s dedicated resource siteDownload the PDF

More Helpful Articles

Reading the FDA Tea Leaves

Looks at the trends impacting FDA and provides several regulatory intelligence insights through 2012 based on analysis presented in Get to Market Now! Turn FDA Compliance into a Competitive Edge and 2011 agency initiatives.  Published in the FDLI Update | Download the PDF

Putting the Biotech Puzzle Pieces Together

Presents a community coalition-based strategy for states and regions interested in growing their biotechnology economies; draws upon lessons learned by Massachusetts, North Carolina, and Florida.  Published in the Virginia Business MagazineGet the PDF

FDA Forecast 2009:  Nine Recommendations to Weather the New Year

With so many pressing issues, where should industry focus its attention and priorities in order to stay out of trouble with FDA?  A special report based on two years of analysis in Cerulean’s SmarterCompliance newsletter.  Originally published in Pharmaceutical ProcessingDownload the PDF

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 BiotechnologyGet the PDF

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