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 and huge losses due to non-compliances, if you want to know the thought process and path which would lead you to qualifying a regulatory inspection with no-observation in cost effective way, then do not miss “Blue Ocean of Compliance”, the 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.
Why you must read this
- By reading and 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 and 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 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.
Chapter One: Why Regulatory Inspections?
Chapter Two: Types of Regulatory Enforcement Actions and Regulatory Actions on Non-Compliances and Devastating effects for the Pharmaceutical Industry due to non-compliances
Chapter Three: Reasons for Non-Compliances
Chapter Four: Actions to be taken
Chapter Five – Part I: Wisdom is to learn from other’s mistakes. (This Chapter contains 12 Case Studies of Warning Letters)
Chapter Five – Part II: Wisdom is to learn from other’s mistakes. (This Chapter contains 492, 483s for 4 years and comparative presentation of these 483s.)
Chapter Six: Blue Ocean of Compliance (New thought process)
Why Regulatory Inspections?
This chapter covers:
- History and story behind regulations and guidelines with a few examples
- Why are Regulatory Audits happening?
- Types of Applications in the US Market
- Investigational New Drug Application (IND)
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Biologics License Application (BLA)
- Drug Applications for Over-the-Counter (OTC) Drugs
- Drug Master File (DMF)
- Orange Book
Types of Regulatory Enforcement Actions and Regulatory Actions on Non-compliances and Devastating effects for the Pharmaceutical Industry due to non-compliances.
This chapter covers:
- cGMP Violations category
- Types of Regulatory Actions
- Impact of the Regulatory Actions
- Criminal Fines for Food, Drug and Cosmetic Act Violations
- FDA Forms 483
- Areas where 483s are given
- Warning Letter
- Warning Letter Close-Out Letter Program
- Criminal prosecution
- Types of Seizures
- Mass and Open-ended Seizures
- Multiple Seizures
- Mass Seizure
- Recall and field correction
- Recall policy
- Understanding Recall Classification
- Recall Events
- Recall Products
- First Alert
- Alerting the Public
- Effectiveness Checks
- Recall Classification
- FDA-regulated Products Subject to Recall
- Field Alert
- IMPORT ALERT
- What are the types of import alerts?
- What is a red, green, and yellow list?
- Drug Product Debarments
- FDA Debarment List
- OIG Exclusions
- Types of Debarments:
- Mandatory Debarment
- Permissive Debarments
To book your copy, visit the link below:
Contact details of Author Dr. Rupali Paranjape:
Catch her on:
YouTube Channel: https://www.youtube.com/channel/UC7BZ0Scd3LjccScLipUVUVQ more.