Holistic Approach Towards Achieving Regulatory Compliance for Pharmaceutical Industries with No-Observation
Are you struggling to solve the problems of non-compliances on your site?
Even with putting your best technologies, Knowledge, and efforts do you feel clueless?
If you want to protect your site from risks & huge losses due to non-compliances,
If you want to know the thought process & path which would lead you to qualify a Regulatory Inspection with no observation in a cost-effective way,
Then do not miss "Blue Ocean of Compliance" #1 Best Seller book on Amazon by Dr. Rupali Paranjape.
“Blue Ocean of Compliance” is a book employing a one-of-a-kind thought process for achieving compliance with no-observation.
It takes you through a guide of Regulatory Inspections elaborated with the US Regulatory Market regard.
This book will not only equip you with regulatory knowledge but will also empower you to solve complicated non-compliances, in the context of factors that we do not even think of. The ideas in this book are very simple to understand.
They will imbibe in you the seeds of "acting to win" instead of only being good enough to survive.
If you are a Founder, a CEO, an entrepreneur, or anyone in the pharmaceutical industry really: if you are a part of the pharmaceutical industry or even are just starting out, this book is a treasure for you.
👉By reading & implementing this you will be able to avoid more than 492, 483s on your site.
👉You will be able to avoid many circumstances that lead to Warning letters.
👉You will become more familiar with the enforcement actions, reasons of non-compliances & ways to overcome them in cost-effective ways.
👉You will come to know many factors which might not be discussed before to solve the non-compliance issues on the site.
👉You will know one new thought process “Blue Ocean of Compliance”
👉At the end of each Chapter Practical Assignments: Exercise is given for implementation.
The beautiful part of the book is, that it is written by an experienced doer that has spent years on the shopfloor in a very simple manner, in easily understandable language with examples, case studies, 492 FDA 483 observations, and many Warning Letter Case studies and much more.
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