SMARTERCOMPLIANCE™ Newsletter

Competitive Knowledge and Compliance Know-How

The first newsletter exclusively devoted to compliance best practices for biotech, pharmaceutical and medical device executives.

 

Free Issue #1   |   Free Issue #2

 

Each monthly issue delivers the latest insights and intelligence on what's working and what's ahead for pharmaceutical compliance ... faster time to market ... cost controls ... quality management ... biotech compliance ... intellectual property security ... data integrity ... IT compliance ... GLP compliance ... GCP compliance ... quality by design ... GMP compliance, and more - long before you see them elsewhere.

 

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Get the latest insights for the best decisions

• Trend analyses
• Practical recommendations
• Concise articles and summaries
• Case studies and models
• An "ask the expert" section
• Featured reading
• Calendar of events

If you want to know how to make compliance easy - whether biopharmaceutical regulations, biotech regulations, EU GMP regulations, FDA regulations, GCP regulations, GLP regulations, IT regulations or data quality regulations - or you want to know how to make compliance cheap - with strategies of lean compliance and lean quality - then you want smart compliance.

 

 

Your key to better compliance, better quality and better profit!

Subscribers get an exclusive members-only private consultation with Cerulean's top international business advisor, speaker and author on regulated product development in the biopharmaceutical and medical device fields, and information to contact the editor for private answers to your questions and much more - all at no extra cost.

 

To subscribe to SMARTERCOMPLIANCE™ (ISSN: 1937-0776), fill out our subscription form.  A subscription is $84 (USD) per year for 12 issues in the United States.  Outside the United States, subscriptions are $129 (USD).  Payment must be drawn upon a US bank account.

 

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If you are not 100% satisfied, you may cancel at any time during your active subscription and request a 100% refund of the price you paid for your current subscription term.  All issues are yours to keep, with no further commitment.

 

Who Should Subscribe

• Executives & managers of businesses
• CEOs and sole proprietors
• Biotechnology venture capitalists
• CFOs, CCOs and CIOs
• General counsels
• Regulatory affairs & quality management directors
• Records management directors
• Privacy and data security professionals
• Independent technology and computer consultants
• Anyone with business interests in faster product development time to market for regulated industries, easier compliance and better investment returns from intellectual property development

 

 

Remember - qualified executives can receive a six month free trial subscription as part of our executive quick-start pack.

 

The newsletter is available toward the end of each month in print and electronic format.  Articles and briefings in the newsletter draw on a variety of sources, including published reports, interviews and research. 

 

Previous Topics - 2008

January:  Nonclinical data integrity ... CEO tips on consultants ... ICH Q8 Annex

February:  Competing against generics ... Protecting your intellectual property

March:  CDER and Quality by Design ... Manage your records securely ... Silent recalls

April:  Expedited review tips ... Improving compliance in an economic slowdown

May:  Part 11 revised ... Mistakes to avoid with CMO/CROs

June:  FDA warnings on data integrity ... Using prison philosophy to improve compliance

July:  Overcoming QbD confusion ... Working with IT to implement PAT ... Biotech and QbD

 

Previous Topics - 2007

January:  FDA guidance... Improving board oversight... Product design transfer

February:  Enforcement trends... Global regulation convergence... Effective policy tips

March:  Adapting to global competition... Clinical study tips... Creating flexible policies

April:  Quality as a competitive advantage... Export compliance... Disclosing decisions

May:  Continuous improvement... Cost-effective financial compliance... Costs control

June:  Quality by design... Joint development agreements... Improving communication

July:  Information integrity... Strategic vendor selection... Running effective meetings

August:  Part 11 compliance roadmap... Managing a crisis... Pushing back on auditors

September:  New FDA surveillance... How to pass an audit... Better decision-making

October:  Prevent IP theft... Streamlining compliance... Resolving conflict on teams

November:  Efficient compliance, Part 2... An update from FDA on quality systems

December:  Better annual reviews... Drawing the line on R&D... 2007 in review

 

Guest Articles

We welcome guest article proposals.  The finished articles must be less than 800 words; we reserve the right to edit for final content.  All submitted articles become the property and copyright of Cerulean Associates LLC and are subject to our terms and conditions.  Send proposals to:  Editor, SMARTERCOMPLIANCE™, c/o Cerulean Associates LLC, PO Box 498, Williamsburg, VA 23187-0498  USA.

 

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