Pharmaceutical Manufacturing Deviation and Failure Investigations

Principles, Practices, and Case Studies
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Éditeur :

Springer

Paru le : 2025-03-20

This book tackles the crucial topic of deviation and failure investigations in the pharmaceutical industry, recognizing their pivotal influence on regulatory outcomes. Extensive assessments, including analyses of US FDA warning letters and 483 reports, underscore the indispensable necessity of a rob...
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Éditeur

Collection
n.c

Parution
2025-03-20

Pages
152 pages

EAN papier
9783031865039

Dr. Ajay Babu Pazhayattil, President, cGMPWorld, Toronto, Canada Dr. Ajay Pazhayattil is an accomplished management consultant and industrial pharmacist with extensive experience spanning solid oral, sterile, and API manufacturing sectors. He is the founder of cGMP World and a founding partner of ITAAN Pharma, an injectable manufacturer. Dr. Pazhayattil has held key leadership positions with prominent North American brands, generic manufacturers, and CDMOs. His roles include Vice President of Scientific and Regulatory Affairs at Capcium, Quality Director at Eurofins, and Associate Director at Apotex. He plays a pivotal role in guiding organizations through remediation efforts related to US FDA 483 observations and warning letters. He has been a lead author and contributor to industry guidance documents published by renowned industry organizations such as AAPS, PDA, ISPE, and RAPS.   Sanjay Sharma, Senior Vice President and Head, Manufacturing Science and Technology, Zydus Group, Ahmedabad, India Sanjay is a seasoned pharmaceutical industry professional with over 25 years of experience in the development, launch, and maintenance of drug supply. He possesses a results-driven approach and a deep understanding of pharmaceutical manufacturing science, which has enabled him to contribute to the success of some of the largest organizations in the industry. Sanjay has held various leadership positions in Indian and multinational pharmaceutical companies such as Cipla, Dr. Reddy's Laboratories, Sandoz, Watson, Torrent, and Lupin. He is widely recognized for his expertise in streamlining technical operations and driving innovation to enhance product quality and regulatory compliance.

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EAN PDF
9783031865046
Prix
94,94 €
Nombre pages copiables
1
Nombre pages imprimables
15
Taille du fichier
10895 Ko
EAN EPUB
9783031865046
Prix
94,94 €
Nombre pages copiables
1
Nombre pages imprimables
15
Taille du fichier
19415 Ko

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