About
Articles by Bikash
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By the Numbers: Understanding COVID-19 Vaccine Effectiveness
By the Numbers: Understanding COVID-19 Vaccine Effectiveness
By Bikash Chatterjee
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Exposing the Soft Underbelly of Pharma’s Global Supply Chain
Exposing the Soft Underbelly of Pharma’s Global Supply Chain
By Bikash Chatterjee
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Exploring Analytical Testing Strategies for Clinical and Commercial Operations
Exploring Analytical Testing Strategies for Clinical and Commercial Operations
By Bikash Chatterjee
Activity
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Has your company ventured into the U.S. generic drug market? Although it might be difficult to understand FDA laws and market dynamics, there is a…
Has your company ventured into the U.S. generic drug market? Although it might be difficult to understand FDA laws and market dynamics, there is a…
Shared by Bikash Chatterjee
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Incredible week in Mexico meeting with AMELAF's constituents. Mexico has always been a strategic partner to the US . They have the potential to…
Incredible week in Mexico meeting with AMELAF's constituents. Mexico has always been a strategic partner to the US . They have the potential to…
Shared by Bikash Chatterjee
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Did you know? The FDA approved 956 generic drug products in 2023. With such a high volume of filings, the FDA is intolerant of incompleteness or lack…
Did you know? The FDA approved 956 generic drug products in 2023. With such a high volume of filings, the FDA is intolerant of incompleteness or lack…
Shared by Bikash Chatterjee
Experience & Education
Publications
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Good Distribution Practices Vol 1
PDA/Davis Healthcare International Publishing LLC
ISBN: 1-978-1-942911-38-8
Chapter 7- The Role of the Qualified Person and Responsible Person in Good Distribution Packages -
Applying Lean Six Sigma In the Pharmaceutical Industry
Gower Publishing
Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the…
Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation.
Each chapter includes discussion around the considerations for applying Lean manufacturing and Six Sigma principles and their tools, culminating in a case study to illustrate the application. The book is organized to reflect the major work centers involved in the drug development lifecycle. Each chapter is stand-alone but together they illustrate the necessary synergy between Lean, Six Sigma and compliance sensibilities required to be successful in the pharmaceutical industry.
These design, manufacturing and management techniques are not without their challenges. Bikash Chatterjee's book offers the roadmap for an industry that is struggling to reinvent many of its development and business processes.
Contents: Preface; The product lifecycle and quality philosophy; Trouble in paradise and catalyzing change; Lean in the product development environment; Applying lean in the analytical laboratory; Applying lean in the pilot plant; Applying lean six sigma on the manufacturing floor; Lean and six sigma as a framework for process analytical technology; Index.
Patents
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Cryogenic Apparatus
Issued US 5, 275, 016
Honors & Awards
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Outsourced Pharma Editorial Advisory Board
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CphI Expert Advisory Board
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Pharmaceutical Manufacturing Editorial Advisory Board
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Languages
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English
Native or bilingual proficiency
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French
Elementary proficiency
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Bengali
Elementary proficiency
Recommendations received
7 people have recommended Bikash
Join now to viewMore activity by Bikash
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The demand for low-cost, high-quality drug offerings in the U.S. is high, with 6.3 billion prescriptions written annually and more than 300 drug…
The demand for low-cost, high-quality drug offerings in the U.S. is high, with 6.3 billion prescriptions written annually and more than 300 drug…
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The demand for low-cost, high-quality drug offerings in the U.S. is high, with 6.3 billion prescriptions written annually and more than 300 drug…
The demand for low-cost, high-quality drug offerings in the U.S. is high, with 6.3 billion prescriptions written annually and more than 300 drug…
Shared by Bikash Chatterjee
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Are you considering bringing your #genericdrug to the U.S. market? One of the most intimidating and essential pieces of U.S. market entry is engaging…
Are you considering bringing your #genericdrug to the U.S. market? One of the most intimidating and essential pieces of U.S. market entry is engaging…
Shared by Bikash Chatterjee
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Are you at BIO 2024 in San Diego today? Look for the Pharmatech Associates, a USP company team. John Aikens, Steve Schiltz, Bikash Chatterjee, and…
Are you at BIO 2024 in San Diego today? Look for the Pharmatech Associates, a USP company team. John Aikens, Steve Schiltz, Bikash Chatterjee, and…
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Great time in Tashkent! I joined Abdulla Azizov, Director of the Pharmaceutical Industry Development Agency, Alisher Temirov, Director of the…
Great time in Tashkent! I joined Abdulla Azizov, Director of the Pharmaceutical Industry Development Agency, Alisher Temirov, Director of the…
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For my friends and colleagues who are caught in what seems to be untenable conflicts between life, work, family and self, please ask me what I am…
For my friends and colleagues who are caught in what seems to be untenable conflicts between life, work, family and self, please ask me what I am…
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