Journal of GXP Compliance
Blueprint for the successful company
“This book provides practical strategies to maximize efficient new product development and supporting compliance structures. It addresses evolving FDA compliance requirements and new product development techniques to facilitate commercialization faster, easier, at less cost, and with less risk. The book describes a systematic and structured new product development process – discovery and preclinical through postmarket – and a regulatory compliance and quality system that will enhance business flexibility and encourage innovation.
The book is well-referenced, and provides supportive source notes and other resources. The website provides supplementary materials such as templates, to-do lists, helpful internet links, and mini-seminars that are supportive to the content of this book.
Mr. Avellanet has provided a blueprint for the successful and compliant company.”
Pharma QbD
Full of very practical tips
“Engaging and very well written … full of very practical tips on how to implement some of the sweeping changes in mindset that smart drug development and manufacturing require, all in bite-sized steps.” Read more online….
GxP Perspectives
A book for compliance professionals
“The book covers today’s regulatory landscape and the importance of quality systems in gaining market approval. Avellanet reviews step-by-step how to incorporate quality into the product development and the post-market compliance standards.” Read more online….
Read the following Amazon reviews to find out what readers think about Get to Market Now!
Great aid for getting a plan in place! June 21, 2010 
“I’m in Regulatory and this book is exactly the tool you need to easily get into compliance for the ‘new’ FDA. It provides helpful hints and checklists that will help guide your steps. It not only provides a regulatory perspective, but shows you how all functional groups need to work together to ensure compliance across the board. Highly recommended for established and new organizations!.”
In a regulatory quandry? Finally, help has arrived! September 24, 2010 “For companies in regulated industries, there can be major problems with implementing the regulations and ensuring compliance. This is particularly true with areas the FDA regulates.
The FDA regulates a vast variety of products including fruit juice, laser light shows, aspirin, and tooth brushes. The complexity of drugs can range from basic aspirin tables to multifaceted drug regimens that may require individual patient genetic information to determine which form is more appropriate. On the device side, this can range from the basic tongue depressor to highly advanced MRI machines that help determine brain functions.
The regulatory structure tends be “old school” with a classic command and control structure, while the new business reality means moving quickly to address business issues. The two approaches create a dichotomy, but, with deep insight, this book creates a meaningful and practical synthesis. For example, the book discuses FDA’s approach for electronic records and electronic signatures (21 CFR Part 11). The regulations haven’t changed in at least 12 years, but computing power and capability double every 24 months (by Moore’s Law).
One of the most valuable, and interesting, aspects of the book is the recognition of the similarity among four sets of FDA regulations: Drug development and manufacture in GMP, Device development and manufacture in QSR, Laboratory practices GLP, and Clinical process in GCP. Most approaches focus on the differences among these approaches. This book recognizes the similarities and demonstrates how executives can take advantage of these similarities to create new and stronger approaches. This kind of thinking offers shorter time to market, a reduced development cost, and stronger regulatory compliance. In short, adopting this methodology can provide a significant and sustainable competitive advantage.
The book achieves this holistic approach to both management and regulatory issues with a four component framework:
* Modern quality systems
* Modern regulatory approaches
* Record retention and control
* Compliance organization
Think of these approaches (integrated GMP, QSR, GLP, and GCP) operating in the holistic framework as the inoculation that prevents problems and allows the firm to excel in the market. In particular, the book points out the issues of implementation in SOPs. While well written SOPs are important, and the book gives good advice, the proof is in the records that demonstrate action. FDA investigators spend little time on SOPs, instead focusing on the records that provide objective evidence. This naturally leads to the tension between keeping everything, in case a regulator asks, and disposing of older records that might create problems in a product liability or regulatory action. The book offers a solid plan backed with examples to deal with this issue.
The book has some additional attributes that provide even more value.
The end of each chapter includes an Executive Checklist. The checklist has specific items, based on the chapter’s information, to turn theory and discussion into effective action and practice. By answering the perennial question, “That’s nice, but what do I do next?” the book effectively moves from theory to practice. This is a pleasant characteristic that gives additional strength to the book.
In addition, the book has an associated website. Instead of the book’s being a static event, the website, well maintained, allows the book to remain fresh and current. “
You can buy Get to Market Now! through Amazon.com, Barnes & Noble, the publisher Logos Press, or your local bookstore
