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This should be mandatory reading for a lot of executives in the industry.”
- Dan Michels, former FDA inspector
Expert advice on
- FDA quality systems
- ICH, EMA, ISO & IMDRF guidelines
- Supplier management & oversight
- FDA enforcement trends
- Records retention and defensible documents
- Lean compliance best practices
- Part 11 & Annex 11 strategies
SmarterCompliance is written to help you meet evolving FDA requirements, bringing you in-depth analysis and advice on new FDA rules and guidance. With SmarterCompliance, you can make the best informed decisions.
Get objective advice and the latest insights on what’s working & what’s ahead for the FDA … for GMP compliance … QSR compliance … FDA inspections and best practices … Part 11 compliance … records & document controls … supplier management … ICH, EMA and IMDRF rules. You’ll always be one step ahead of regulatory developments.
FDA expert advice for the best decisions
- Concise strategies to balance business & compliance
- Case studies and practical “how to” articles
- Tips from former FDA officials & industry experts
- New regulatory guidance analysis
- FDA enforcement reviews with recommendations to keep you ahead of the investigator
- Emerging FDA expectations
- Highlights of the impact of new legislation, regulations, and guidelines
We cut through the clutter, put our recommendations up front and give you advice you can trust. Regular industry publications look backward. SmarterCompliance looks ahead, anticipating what’s next: a turn in FDA enforcement, a shift in global harmonization, device regulation convergence, and other key trends. See what readers and former FDA officials say.
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- Exclusive year-end FDA forecast and planning issue with reliable advice on what will happen next for FDA compliance – and how you can take advantage
- Regulatory documents and presentations from FDA, ICH, EMA, IMDRF and more
- The latest outlook for quality system trends and best practices
- Periodic email alerts on breaking compliance news with specific recommendations
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Regulatory and quality systems advice you can count on.”
- Carl Anderson, former FDA inspector
Prepare for the regulatory landscape ahead and subscribe today
Who should subscribe
- Corporate executives & senior managers
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- Anyone with decision-making authority interested in cost-effective compliance
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See what readers say
Written for Cerulean’s consulting clients & individual subscribers, each SmarterCompliance newsletter is designed to help you reduce risk, boost productivity, and improve the effectiveness of your quality systems and compliance activities.
A perfect blend of reliable advice and expert analysis. Your newsletter really shows how quality and regulatory affairs teams can play a better strategic business role.”
- S. Upadrashta, Vice-President, Regulatory Affairs & Quality, California
SmarterCompliance is a unique and well-needed voice on the industry.”
- M. Stawicki, Director, Regulatory Affairs, UK
Incredibly well-written and well worth it.”
- T. Winchell, former FDA inspector, Kansas
Should be mandatory reading for a lot of executives in the industry.”
- D. Michels, former FDA inspector, Maryland
Your newsletter continues to add lots of value to my thoughts in regulatory and compliance understanding.”
- A. Agarwal, Director, Quality, India
Tells you exactly what you need to know – and how to stay one step ahead. It has helped so much.”
- A. Fauchier, Director, Regulatory Affairs & Quality, Georgia
Full of great real-world examples and tips.”
- C. Pillar, Director, Quality, Illinois
Like getting an expert FDA consultant’s advice all throughout the year.”
- M. Weber, Director, R&D, Virginia
Expert quality systems advice you can count on.”
- C. Anderson, former FDA inspector, Washington
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The SmarterCompliance newsletter is published six times a year in print and digital format.
We welcome guest article proposals and suggestions for interviews. Finished articles must be approximately 1,200-2,000 words; we reserve the right to edit for final content. Contact us directly or send proposals to: Editor, SmarterCompliance newsletter, c/o Cerulean Associates LLC, PO Box 498, Williamsburg, VA 23187-0498 USA.